WORLD TRADE  
ORGANIZATION  RESTRICTED 
G/TBT/M/54 
20 September 2011 
 (11-4529) 
Committee on Technical Barriers to Trade  
  
MINUTES OF THE MEETING OF 15-16 JUNE 2011 
 
Chairperson:  Ms Denise Pereira (Singapore) 
 
Note by the Secretariat1 
 
 
 
I.  ADOPTION OF THE AGENDA ............................................................................................. 2  
II.  IMPLEMENTATION AND ADMINISTRA TION OF THE AGREEMENT .................... 2  
A.  STATEMENTS FROM MEMBERS UNDER ARTICLE 15.2 .................................................................. 2  
B.  SPECIFIC TRADE CONCERNS  ........................................................................................................ 2  
C.  EXCHANGE OF EXPERIENCES  .................................................................................................... 64  
D.  OTHER MATTERS  ...................................................................................................................... 71  
III. TECHNICAL COOPERATION ACTIVITIES ................................................................... 71  
IV.  OBSERVERS ..................................................................................................................... ..... 71 
A.  UPDATE FROM OBSERVERS  ....................................................................................................... 71  
B.  REQUESTS FOR OBSERVER STATUS IN THE TBT COMMITTEE  ..................................................... 72  
V.  DATE OF NEXT MEETING ................................................................................................ 73  
 
                                                      
1 This document has been prepared under the Secret ariat's own responsibility and is without prejudice 
to the positions of Members and to their rights and obligations under the WTO. G/TBT/M/54 
Page 2  
 
  I. ADOPTION OF THE AGENDA  
1. The Committee adopted the agenda contained in WTO/AIR/3751. 
II. IMPLEMENTATION AND ADMINISTRATION OF THE AGREEMENT 
A. S
TATEMENTS FROM MEMBERS UNDER ARTICLE 15.2   
2. The Chairperson said that the latest list of st atements submitted under Article 15.2 of the TBT 
Agreement is contained in document G/TBT/GEN/1/ Rev.10, issued on 22 February 2011.  She noted 
that, since the last meeting, Kuwait (G/TBT/A dd.2/105) and Zambia (G/TBT/2/Add.106) have 
submitted their statements under Article 15.2 an d Croatia (G/TBT/2/Add.73/Rev.1) and Ukraine 
(G/TBT/2/Add.100/Rev.1) have submitted Revisions to their original statements.  In total, since 1995, 
123 Members had submitted at least one Statemen t on Implementation under Article 15.2.  She 
recalled that this information was available, a nd regularly updated, on the TBT page of the WTO 
website and in the TBT Information Management System (the IMS).  The latest list of enquiry point 
contact is contained in document G/TBT/ENQ/38, issued on 30 May 2011. 
B. SPECIFIC TRADE CONCERNS  
1. New Concerns  
(i) Australia – Tobacco Plain Packaging Bill 2011(G/TBT/N/AUS/67) 
3. The representative of the European Union rai sed some questions about Australia's proposed 
"Tobacco Plain Packaging Bill 2011" notified to the TBT Committee.  She noted that the draft 
measure aimed, inter alia , at restricting advertising or promo tion on packaging of tobacco products by 
imposing "plain packaging" for all tobacco products so ld in Australia by 1 July 2012.  According to 
the proposal, the only allowed feature on the pack age would be the brand name, displayed in a 
standardised font, size, colour and location on th e package. The rest of the package would contain 
textual and pictorial health warnings.    
4. The European Union noted that it was also in  the process of revising its so-called "Tobacco 
Products Directive" and that plain packaging w as among the possible future policy options being 
considered in the on-going impact assessment.  In this context, the European Union asked Australia 
what scientific data or other relevant informa tion had been considered that focused on the link 
between plain packaging and reducing the appeal of tobacco products to consumers, and whether 
these studies could be made available to the Committ ee.  Furthermore, while the European Union had 
examined the "Plain Packaging of Tobacco Products Consultation Paper"2, the EU delegation asked 
for some additional information. In particular, s hould an impact assessment have been carried out 
prior to the on-going consultation, the EU enquire d with Australia whether it could share this 
document, or a summary of its conclusions, with other Committee members. 
5. The representative of the European Union also asked whether Australia had evaluated other 
legislative solutions and why these alternative so lutions had been considered less effective for 
achieving the legitimate health objective pursued.  Furthermore, the European Union noted that 
Australian authorities had in the TBT notification referred to Australia's obligations under the WHO 
Framework Convention on Tobacco Control (FCTC) , which the European Union and 26 of its 
Member States were also parties to.  In this cont ext, the European Union was interested to know how 
Australia had taken into account its commitments under other international agreements, including the 
WTO Agreement on Trade-Related Aspe cts of Intellectual Property Rights (TRIPS).  Finally, the 
                                                      
2 http://www.yourhealth.gov.au/internet/yourhea lth/publishing.nsf/content/plainpack-tobacco .  G/TBT/M/54 
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  representative of the European Union asked Austra lia to provide information about the envisaged 
legislative process and the timing for the adoption of the proposal. 
6. The representative of the Dominican Republic ra ised a number of concerns and questions 
with respect to the Australian draft measure.  These are reflected in full in G/TBT/W/339, dated 
21 June 2011.    
7. The representative of Indonesia also raised a num ber of concerns and questions with respect 
to the Australian draft measure.  These are reflect ed in full in G/TBT/W/336, dated 8 June 2011. 
8.  The representative of Mexico noted that while her delegation shared Australia's interest in 
protecting the health of consumers, Mexico ne vertheless had some concerns - both on TBT and 
TRIPS.3  Essentially, Mexico was of the view that the measure was more trade restrictive than 
necessary to achieve the stated policy objective.  It was Mexico's understanding that there was no 
scientific information that indicated that the design of the box had a direct impact on the level of consumption or the attractiveness of tobacco amongst th e population.  Hence, in this case, trade would 
be restricted because producers would need to manufacture a plain or generic box to access the 
Australian market - and this without evidence that such efforts would lead to a drop or reduction in 
attractiveness of tobacco amongst the populatio n, particularly amongst young Australians. 
9. The representative of China said that his delega tion shared the concerns expressed by other 
Members and would closely monitor this issue. 
10. The representative of Chile joined the concerns expressed by delegations before him.  While 
supportive of the legitimate public health objectiv e sought, the proposal, in his delegation's view, 
raised several issues.  To begin with, it appeared to be more restrictive than necessary because there 
did not seem to be any scientific evidence lendi ng support to "plain packaging" as a means of 
effectively addressing the objectives that Australia wish ed to achieve; indeed, what was the scientific 
basis Australia was relying on?  Could not, he ask ed, the same objective be achieved through the use 
of better, newer information in visible health warnings without  affecting the legitimate use of the 
brand names to differentiate between manufacturers.  With respect to the WHO, the FCTC provisions 
were extremely general in nature - they did not go to the level of specificity set out in the Australian 
draft measure.  Also, special and differential treatment  needed to be considered; in particular Article 
12.3 of the TBT Agreement was relevant.  The ar ticle emphasized that in the preparation and 
application of technical regulations, standards and conformity assessment procedures, Members 
needed to take account of the sp ecial development, financial and tr ade needs of developing country 
Members, with a view to ensuring that such m easures did not create unnecessary obstacles to exports 
from developing country Members.  The representativ e of Chile also asked Australia to confirm the 
viability and effectiveness of the dates for adoption and entry into force.   
11. The representative of Colombia questioned the ju stification of the measure under Article 2.2 
of the TBT Agreement; in Colombia's view, the measu re appeared to be more trade restrictive than 
necessary to achieve the public health  objective sought.  In fact, the imposition of the proposed policy 
could have an impact on other legitimate objectiv es set out in the TBT Agreement regarding the 
prevention of deceptive practices.  Indeed, pi ctograms and holograms were currently being 
implemented by several countries with the aim of in forming the consumer of various adverse health 
effects.  Yet it had not been scientifically proven that these labels directly induced a drop in consumption of tobacco.  Could Australia, therefore,  provide evidence (scientific studies) that proved 
that the prohibition of the use of cigarette brands would lead to a drop in consumption of tobacco by 
                                                      
3 Comments on aspects related to intellectual property rights were made in the context of the 
7 June 2011 meeting of the TRIPS Council. G/TBT/M/54 
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  consumers under the age of 18?  These studies were  important because they needed to serve as the 
basis for impact analysis.  In addition, had Australia carried out a cost-benefit analysis? 
12. The representative of Cuba acknowledged the priori ty given to the public health objective as 
such.  Nonetheless, by prohibiting the use of bra nd designs on packaging, the proposed legislation 
made it difficult for retailers and consumers to identify and recognize the brand of their choice.  
Clearly, this undermined the value of brands, which had been built up over the course of many years.  
In addition, the new regulation would oblige manufact urers exporting to Australia to comply with a 
new packaging requirement for that market alone .  This would lead to very high costs which would be 
practically impossible to bear for companies from developing countries.  Moreover, if this same regulation were applied to other products, the impact on international trade would be significantly 
expanded. In addition, there was the risk that price would become the only differentiating factor 
between tobacco products on the market, driving down the average and premium price of products, 
meaning that smoking would become cheaper, having the unwanted effect of increasing  total 
consumption.  A drop in prices would also have a ne gative effect on international trade, particularly 
for those countries that produced t obacco.  It was also likely, in the view of the Cuban delegation, that 
plain packaging would lead to an  increase in the illicit trade of t obacco products in the Australian 
market, given that it would be easier to counterfeit a plain package.  This coul d, in addition, promote 
the smuggling of genuine packages to satisfy the demand.   
13. The representative of Cuba stressed that there w as no reliable proof or evidence that showed 
that plain packaging influenced consumers' beha viour, or contributed to dissuading young people 
from smoking.  Indeed, there was no guarantee that af ter having imposed this new technical regulation 
the Australian authorities would achieve the health objectives they were seeki ng.  Existing studies did 
not examine or validate the genuine effect of th e packaging design on the decision to smoke or not; 
therefore, packaging design was not a reliable be nchmark to take into account when regulating a 
smoking or tobacco use.  For these reasons, the represen tative of Cuba was of the view that the draft 
measure was not consistent with Article 2.2 of the TBT Agreement because it restricted trade more 
than necessary to obtain the public health objectives declared by the Australian government. He noted 
that a number of questions posed by Cuba, and which had also been delivered to the Australian 
Enquiry Point were circulated separately in document G/TBT/W/338, dated 10 June 2011. 
14. The representative of Nicaragua supported the st atements made by previous speakers, in 
particular the points relevant to articles 2.2 and 12 .3 of the TBT Agreement.  Specifically, she noted 
that when assessing risk under Article 2.2, re levant elements of consideration were inter alia  available 
scientific and technical information, related proces sing technology or intended end-users of products. 
In Nicaragua's view, there was no available scientific and/or technical information clearly showing that packaging would impact on consumers' behavi our.  Instead, the bill would create difficulties in 
particular for products entering the Australian market.  She recalled Article 12.3 of the TBT 
Agreement and noted that the measure would creat e an unnecessary obstacle to products originating 
in developing countries.  Indeed, the law would aff ect the productive capacity of the tobacco sector in 
Nicaragua.  Moreover, the measure was not only cont rary to the TBT Agreement but also the TRIPS 
Agreement as well as other intern ational agreements, such as the Paris Convention for the Protection 
of Industrial Property - a point Nicaragua had made  at the meeting of the TRIPS Council on 7 June 
2011.   
15. The representative of Ukraine drew the Committee' s attention to an appeal from the Ukrainian 
tobacco industry concerning the effect of the propo sed measure on international trade.  After careful 
examination of the notification and proposed legisl ation, Ukraine had come to the conclusion that 
adoption of current version of the proposal would violate a number of WTO obligations, including  G/TBT/M/54 
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  those under the TBT and TRIPS Agreements.  Ukraine made a statement at the TRIPS Council4 
regarding the TRIPS-related concerns.  With respect  to TBT, Ukraine considered that the proposed 
legislation was more trade-restrictive than necessary to fulfil the legitimate objective. The effect of the 
enactment would be the removal of all distingu ishing trademarks, designs, logos, and colour 
characteristics from the packaging of branded toba cco products. This would make it difficult to 
identify and recognize specific branded products.  In turn, this would make it extremely hard, if not 
impossible, for any manufacturer of tobacco products not currently present in the Australian market to 
enter it.  The potential adverse impact on internatio nal trade of tobacco products with Australia was 
therefore significant.  In addition, the measure coul d not - in Ukraine's view - be justified under the 
FCTC because plain packaging requirements went far beyond the obligations set out within the 
FCTC.   
16. The representative of Ukraine then asked a numbe r of questions:  Had Australia examined the 
extent to which the proposed limitation on the use of  brands would have an impact on trade in the 
different like products covered by the proposed meas ure?  Had any studies other than those listed in 
the consultation paper been examined?  If there ha d indeed been such stud ies and their outcomes 
differed from those of the studies listed in the consultation paper, how had these outcomes been 
factored into the proposed legislation?  Had Aust ralia examined the material contribution of existing 
measures to the achievement of the health policy objectives of the proposed legislation?  If so, had 
improving existing measures been considered as an option?  Had Australia analysed the potential 
trade impact of the proposed measures, includi ng the potential impact on trade with developing 
countries? If so, what were the results of these anal yses?  To what extent had Australia considered 
alternative measures that would achieve the same health objectiv es without creating an unnecessary 
obstacle to trade? If less trade-restrictive alterna tive measures had been considered and rejected, why 
had they been rejected? 
17. The representative of Turkey expressed interest  in Australia's responses to the questions 
raised at the meeting. 
18. The representative of Switzerland said that while  his delegation shared Australia's concern 
about the damaging effects of smoking on individuals and public health, the right balance needed to 
be struck between health measures and WTO oblig ations; and the measure had to be supported by 
relevant evidence.  Switzerland therefore invited Aust ralia, when reviewing the plain packaging bill to 
bear in mind that technical regulations needed not to  be more trade-restrictive than necessary to fulfil 
a legitimate objective.  Switzerland had also  raised concerns in the TRIPS Council. 
19. The representative of Honduras, like other de legations, understood the underlying health 
objective.  Nevertheless, her delegati on had concerns of a systemic natu re in relation to Article 2.2 of 
the TBT Agreement.   Because there was no eviden ce that plain packaging would in any way affect 
consumers' behaviour, imposing the said measure would restrict trade without necessarily meeting the objective that Australia had set out to achieve.  Mo reover, the TBT Agreement in Article 12.3 stated 
that Members had to ensure that technical regulations would not create unnecessary obstacles to 
exports from developing country Members.   
20. The representative of Norway stressed that it w as well within Members' rights to implement 
the necessary measures in order to protect public hea lth.  Australia's proposed measure was interesting 
in this respect and merited further consideration.  Norway trusted that the Australian measure would 
be implemented in a manner that was consistent with its WTO obligations.  She noted that Norway 
had also implemented a number of measures to combat smoking. 
                                                      
4 Comments on aspects related to intellectual property rights were made in the context of the 
7 June 2011 meeting of the TRIPS Council. G/TBT/M/54 
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  21. The representative of Uruguay stressed that Article XX of the GATT (General Exceptions) 
stated that no provision should be interpreted as impeding any contracting party from adopting or 
applying any necessary measures to protect the life and health of people.  Uruguay was strongly of the view, as a general principle, that public health protection was under the competence and sovereignty 
of all States.  This had also been recognized in the WHO Framework Convention on Tobacco Control 
(FCTC).  The 172 parties to that Convention had reaffirmed their efforts to give priority to applying 
health measures for tobacco control, and said that  this was crucial for establishing national health 
policies to protect the population.   In Uruguay, for example, tobacco control policies had led to a 
decrease of 24 per cent of daily smokers; reduced air- pollution in enclosed areas by more than 90 per 
cent; and, reduced hospital admittances for heart-atta cks and other tobacco-related afflictions by more 
than 17 per cent as compared to the situation be fore the policies had been implemented.   
22. Considering the devastating consequences at sever al levels (health, social and environmental) 
there was a clear trend among States to apply measur e for tobacco control.  Clearly, tobacco control 
was a legitimate objective to protect health a nd life of persons under Article 2.2 of the TBT 
Agreement.  Indeed, the representative of Uruguay st ressed, Article 2.2 referred specifically to "risks 
of non-fulfilment".  Moreover, in respect of Article  12.3, which stated that Members needed to make 
sure that their technical regulations would not represent an unnecessary obstacle to exports of 
developing countries, Uruguay stressed that the protec tion of life and health of persons was not an 
unnecessary obstacle - it was, in fact, a very important  requirement.  Hence, the measure proposed by 
Australia was in line with the commitments which Uruguay had taken before the WTO.  
23. The representative of the Philippi nes shared the concerns expressed by other delegations who 
had spoken, particularly on how the draft measure appeared to be more trade restrictive than 
necessary and the apparent lack of evidence to back it up. 
24. The representative on New Zealand noted that the negative effects of tobacco could not be 
overstated.  In New Zealand this was one of the lead ing preventable causes of early death.  Therefore, 
New Zealand welcomed the Australian Government's d ecision to take this measure in order to protect 
public health and human life, and trusted that it w ould be implemented in a TBT-consistent manner. 
25. The representative of Australia said that the proposed legislation on plain packaging of 
tobacco products was being implemented in the inte rest of public health.  The draft legislation had 
been subject to an open consu ltation process, including with Australia’s trading partners, which had 
begun 7 April 2011.  The consultation period closed  on 6 June 2011 and comments lodged were being 
considered by the Australian Government.  Th e legislation was expected to commence on 
1 January 2012, and would require all tobacco products offered for retail sale on or after 1 July 2012 
to be compliant.  In crafting the legislation and ot her measures related to tobacco, Australia had paid 
full regard to the rights and obligations unde r the TBT Agreement and other relevant WTO 
commitments.  Australia would ensure that the policy would be implemented in a manner that was 
consistent with those commitments.   
26. In terms of context, the measure was neither su rprising nor new.  Australia had been a global 
leader in tobacco control for over 30 years and had implemented, over that period, a number of 
measures designed to reduce smoking rates.  Th ese measures included: extensive and continuing 
public education campaigns on the dangers of smoking;  age restrictions on tobacco purchase; pricing 
measures through excise and customs duties; compre hensive bans on tobacco advertising, promotion 
and sponsorship; bans on smoking in certain place s to reduce the impact of second-hand smoking, 
particularly on children; bans and restrictions on the retail display of tobacco products; and mandatory 
graphic health warnings on tobacco product packagi ng.  Over the years, Australia had made some 
progress in reducing smoking rates and thereby the h ealth impacts of smoking on individuals and the 
community at large but, despite all of these actions, the fact remained that some 3 million Australians  G/TBT/M/54 
 Page 7 
 
 
  smoked every day.  Smoking still killed over 15,000 Australians every year and cost Australia’s 
society and economy over AUD 31.5 billion every year. 
27. The proposed plain packaging legislation was therefore one of several of new measures 
designed to further decrease smoking rates.  Othe r elements of the current package included a 
25 per cent increase in tobacco excise tax.  Austra lia's tobacco excise and excise-equivalent duty was 
high by international standards; it currently amounted to around AUD 8.40 on a packet of 
25 cigarettes, and AUS 10.09 on a packet of 30.  Au stralia had increased investment in anti-smoking 
social marketing campaigns and had also added legisl ation to bring restrictions on tobacco advertising 
on the internet into line with restrictions in other media and at retail points of sale. 
28. It was noted that the suite of measures had been recommended by Australia’s leading public 
health experts on the National Preventative Health  Taskforce, and these had been accepted by the 
Australian Government.  The Taskforce had consid ered that plain packaging would improve public 
health by: (i) reducing the attractiveness and appeal  of tobacco products to consumers; (ii) reducing 
the ability of tobacco packaging to mislead consumers about the harmful effects of smoking; and, (iii) increasing the noticeability and eff ectiveness of mandated health warnings. 
29. The representative of Australia noted that tobacco  packaging was, simply put, one of the last 
remaining forms of tobacco advertising in Australia  and plain packaging legislation was therefore the 
next logical step in Australia’s tobacco control effo rts.  It was noted that guidelines had been agreed 
by the Conference of the Parties to the WHO FCTC, in 2008, for the implementation of Articles 11 and 13 of the FCTC: these recommended that Parties consider the introduction of plain packaging.  
30. The recommendations of the National Preventa tive Health Taskforce had been based on 
extensive research and evidence that carefully expl ored the impact of tobacco packaging, and had 
tested the reactions of respondents exposed to different packaging options under experimental 
conditions.  The research evidence was set out in the reports of the Preventative Health Taskforce in 
2009 and listed 12 peer-reviewed research papers since 2004 alone.  All of these were available 
publicly and the representative of Australia offered to  distribute them.  A further nine studies had been 
submitted in the Consultation Paper that accompanie d the draft legislation.  In addition, on 
24 May 2011, the Cancer Council of Australia ha d released a review presenting evidence from 
research over two decades across five countries from 24 published experimental studies.  Key findings 
(also available in the public domain) were as follows: 
(a) young adult smokers associate cigarette brand names and package designs with 
positive personal characteristics, social identity and aspirations;  
(b) packaging can create misperceptions about the relative strengths, level of tar and 
health risk of tobacco products;  
(c) decreasing the number of design elements on a cigarette pack reduces its appeal and 
perceptions about the likely enjoymen t and desirability of smoking; and, 
(d) plain packaging increases the impact of health warnings. 
31. Thus, in Australia's view, the weight of th e evidence indicated that a plain packaging 
requirement, as part of a comprehensive suite of tobacco control measures, would help to reduce 
smoking rates.  The representative of Australia noted that a number of Members had specifically referred to studies by the firm Deloitte released in May 2011 which claimed to find no relationship 
between the tobacco regulation on p ackaging and changes in consumpti on.  In this respect, Australia 
noted that this study had been commissioned by,  and funded by, British American Tobacco.  
Moreover, history suggested that Me mbers needed therefore to treat th is study with considerable care G/TBT/M/54 
Page 8  
 
  because, from the Australian perspective, it containe d a number of misleading statements.  Moreover, 
aspects of its analysis were based on assumptions wh ich were incorrect or highly selective in the use 
of data - which, again, had been pr ovided solely by the tobacco industry. 
32. The representative of Australia noted that there had been some claims to the effect that 
Australia’s plain packaging proposal would have a significant impact on the illicit trade in tobacco 
products.  Australia did not accept this.  As a matt er of fact, it was important to understand that 
counterfeiters already had very little trouble replica ting branded tobacco packages.  Nevertheless, the 
use of anti-counterfeiting markings would be allo wed on packaging, provided that these markings 
were not associated to tobacco marketing or promo tions.  In any event, smoking any tobacco product, 
licit or illicit, was fundamentally harmful to human health.  
33. The representative of the WHO said that tobacco use was one of the greatest threats to public 
health the world had ever faced.  Consumption of tobacco currently killed nearly six million people a 
year through direct use and the deadly effects of second-hand smoke.  An average of one person every 
six seconds and one in 10 adults succumbed to tobacco use.  Tob acco was indeed the single most 
preventable cause of death in the world today.  He  said it was the only legal consumer product that 
killed up to half of those who used it as intende d and recommended by the manufacturer.  Moreover, 
tobacco was a prominent risk factor for 6 of the 8 leading causes of death in the world.  The economic 
costs of tobacco use were as devastating as the public health costs, killing people at the height of their 
productivity.  Yet these disastrous consequences con tinued in large part due to aggressive and 
widespread marketing and practices by multinational tobacco companies, including through the use of 
targeted and precisely designed tobacco product pack aging aiming to initiate and maintain addiction 
among consumers. 
34. The representative of the WHO noted that a strong and irrefutable body of evidence had 
demonstrated that product packaging has traditionally  served as one of the tobacco industry’s central 
vehicles in initiating and maintaining addiction.  For example, detailed analyses of tobacco industry 
documents had illustrated that tobacco companies viewed product packaging as a critical marketing 
strategy in promoting brand image in order to in crease their market share, and target vulnerable 
segments of the population, including women and children. 
35. Peer-reviewed research indicated that plain packaging on tobacco products would increase the 
impact of health warnings, reduce false and mi sleading messages that deceive customers into 
believing that some tobacco products were safer th an others, and reduce the attractiveness of products 
to segments of the population specifically targeted by tobacco companies.  Give n that the majority of 
smokers began a lifetime of addiction before the age of 18, plain packaging would severely restrict the 
industry’s capacity to appeal to young people.  The representative of the WHO also noted that in the 
context of the tactics employed by the tobacco  industry to use tobacco packaging to mislead 
consumers concerning the level of risk to whic h consumers were exposed, plain packaging also 
circumvented and avoided communicati on of disparate levels of harm. 
36. The representative of the WHO went on to note  that even in the face of overwhelming 
evidence, the tobacco industry wo uld vehemently lobby in oppositi on to the introduction of plain 
packaging legislation.  Fundamentally, the intr oduction of plain packaging would represent the 
inability of tobacco companies to appeal to consumer s in ways to which they were accustomed, and, 
in this way, could affect the tobacco industry’s econo mic interests.  It was important to note, he said, 
that this nature of opposition to effective tobacco control policies was a traditional tactic employed by 
the tobacco industry as tobacco companies for d ecades had operated to expand market share. 
37. WHO was of the view that the legitimate t obacco control measures being discussed at the 
WTO would have a substantial impact on tobacco cons umption and, in turn, on the national burden of  G/TBT/M/54 
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  disease attributed to non-communicable diseases, which represented 60 per cent of all deaths 
worldwide.   
38. It was pointed out that the WHO FCTC was th e first international treaty negotiated under the 
auspices of the WHO.  It had been developed in r esponse to the globalization of the tobacco epidemic 
and was an evidence-based treaty that reaffirmed th e right of all people to the highest standard of 
health. It had been adopted by the World Health Assembly on 21 May 2003 and had entered into force 
in February 2005.  It had since become one of the most rapidly and widely embraced treaties in UN 
history.  The Convention currently had 173 Parties;  indeed, of the 153 WTO Members, 138 were also 
Party to the FCTC and thus subject to the obligations contained in the FCTC.   
39. The representative of the WHO noted that Article 3 of the FCTC Convention set out the 
collective objectives of the Parties in negotiating the Convention as follows:  
"to protect present and future generations  from the devastating health, social, 
environmental and economic consequences of  tobacco consumption and exposure to 
tobacco smoke by providing a framework for tobacco control measures to be implemented by the Parties at the national, regional and internati onal levels in order 
to reduce continually and substantially the prevalence of tobacco use and exposure to 
tobacco smoke." 
40. It was pointed out that the general obligations of the Parties to the WHO FCTC were set out 
in Article 5 of the Convention, and included the development and implemen tation of comprehensive 
multisectoral national tobacco control strategies,  plans and programmes, in keeping with the 
Convention and any future protocols.  In addition,  Paragraph 2b of Article 5 made clear that each 
Party to the Convention had committed itself to adop ting, implementing and periodically updating and 
reviewing effective legislative, executive, administrative and/or other measures aimed at inter alia  
preventing and reducing tobacco consumption. 
41. In addition to these general obligations, the representative of the WHO noted that the 
convention contained a number of specific obliga tions to which parties had committed themselves, 
including in Article 7, the Parties' obligation,  through the Conference of Parties, to propose 
appropriate guidelines for the implementation of Artic les 8 to 13 of the Framework Convention.  Also 
in terms of specific obligations, Article 11 of th e Convention required Partie s to adopt and implement 
effective measures in respect of the packaging a nd labelling of tobacco produ cts, including health 
warnings and other appropriate messages. 
42. The representative of the WHO said that in re lation to the obligation in Article 13 of the 
Framework Convention, which needed to be read  in light of the broad definition of “tobacco 
advertising and promotion”  which was contained in Article 1(c) as follows: “‘tobacco advertising and 
promotion’ means any form of commercial communi cation, recommendation or action with the aim, 
effect or likely effect of promoting a tobacco product  or tobacco use either directly or indirectly”.  
Article 13 of the Convention required Parties to  undertake a comprehensive ban of all tobacco 
advertising, promotion and sponsorship. 
43. On the Guidelines for implementation, Article 7 required the Conference of the Parties, which 
comprised all Parties to the Convention, to adopt guidelines for the implementation of certain of the 
obligations outlined above.  The preparation of these Guidelines was, it was emphasized, an 
intergovernmental process in which the Parties to  the Convention created working groups where the 
text of the guidelines was elaborated by representa tives nominated by those Parties before being sent 
to the Conference of the Parties – the governing body of the convention – for consideration and 
adoption.  The Conference of the Parties had, in  fact, adopted all guidelines by consensus.  In G/TBT/M/54 
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  addition, the resources and references used in the development of the guidelines for implementation 
were available to the public on the WHO FCTC website. 
44. The Guidelines on Article 11 stated as their agreed  purpose "to assist Parties in meeting their 
obligations under Article 11 of the Convention, a nd to propose measures that Parties can use to 
increase the effectiveness of their packaging a nd labelling measures."  The Article 11 Guidelines 
specifically included the adoption of plain packagin g of tobacco products.  The Guidelines of Article 
13 indicated that their stated purpose "is to assist Pa rties in meeting their obligations under Article 13.  
They draw on the best available evidence and the experience of Parties that have successfully 
implemented effective measures against tobacco a dvertising, promotion a nd sponsorship".  The 
guidelines then, for the implementation of Article 13,  also specifically addressed the issue of adopting 
plain packaging of tobacco products as a means of implementing Party obligations to undertake a 
comprehensive ban of all tobacco advertising, promotion and sponsor ship pursuant to Article 13. 
45. In addition, the representative of the WHO noted two recent decisions of the Conference of 
the Parties of the FCTC, which had taken place in  November 2010 (its fourth session in Punta del 
Este, Uruguay).  The first Decision of interest wa s the Punta del Este Declaration (FCTC/COP4(5)), 
regarding public health policy, international trad e and the activities of the tobacco industry.  It 
specifically referenced provisions of the TBT Ag reement and the TRIPS Agreement, and the Doha 
Declaration on the TRIPs Agreement and Public  Health.  The second COP Decision requested, inter 
alia, the FCTC Secretariat to cooperate with the WTO Secretariat with the aim of information sharing 
on trade-related tobacco control issues. 
46. The representative of the WHO also noted that wi th respect to counterfeit products and illicit 
trade there existed a protocol on illicit trade in tobacco products currently under negotiation by the 
Parties to the FCTC.  The final session of this inte rgovernmental negotiating body was expected to be 
held in March 2012. 
(ii) Korea – Regulation on Registration and Evaluation of Chemical Material 
(G/TBT/N/KOR/305) 
47. The representative of China expressed appreciati on for the fruitful bilateral discussion of the 
above-mentioned regulation with the Korean delegation, and was pleased to learn that a formal reply 
to China's written comments was forthcoming.  He raised three points of concern. First, the representative noted the content of the regulation wa s unclear in several parts. For example, the 
"Presidential Proclamation" and "Order of the Minist ry of Environmental Protection" were cited many 
times in the regulation but no references were give n to specific clauses.  He invited the Korean 
authorities to further clarify the draft regulation in order to improve understanding. 
48. He also observed that toxic chemicals were cla ssified in the draft regulation according to the 
"Presidential Proclamation", which was not in accordance with the provisions of Globally Harmonized System of Classification of Labelling of Chemicals (GHS) of the United Nations. The representative invited Korea to use the GHS as the basis of its regulation so as to avoid unnecessary 
obstacles to international trade in accordance with Article 2.4 of the TB T Agreement.  In addition, the 
draft regulation failed to consider existing actions  and outcomes of international chemical risk 
evaluation and international data for mutual rec ognition, which contravened the recommendations of 
the United Nations.  He quoted Article 19.4 of Un ited Nations Agenda 21, which explicitly proposed: 
"expanding and accelerating international assessm ent of chemical risks; harmonization of 
classification and labelling of chemicals; and, info rmation exchange on toxic chemicals and chemical 
risks."
5  The representative of China emphasized the cr itical role of international cooperation in 
reducing chemical risks, while ensuring smooth trad e flows.  He asked the Korean delegation to 
                                                      
5 http://www.un.org/es a/dsd/agenda21/res_agenda21_19.shtml .  G/TBT/M/54 
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  explain its future plans for this legislation and its implementation, and how  international work had 
been - and would be taken into account. 
49. While the representative of the United States shar ed Korea's objectives of safeguarding public 
health and the environment, he noted concerns about the broad implications of the regulation; 
implications which applied not only to US industr y, but to Korean industry as well.  He said US 
industry had expressed various concerns with th e proposed measure, and noted that Korean 
manufacturers relying on imported chemicals could be faced with a decision to curtail or stop domestic production as a result of costly and burdens ome elements of the regulations.  Given the 
complexity of the measure, the United States had re quested an extension to the comment period in 
May 2011 which was declined.  Nevertheless, he hoped that Korea would be able to fully engage with 
US industry to address concerns before finalizi ng the measure.  The US Environmental Protection 
Agency (EPA) had already begun discussing this issue with Korean regulators in Washington to explore working together to share information, and to discuss respective approaches to chemicals 
assessment and management systems. 
50. The US representative raised a number of preliminary questions and comments on the draft 
measure. First, he understood that there would be  additional implementing regulations forthcoming, 
namely a Ministry enforcement rule and a Presidential Decree.  Assuming that these were TBT measures, he inquired whether Korea intended to no tify them.  He also sought information on which 
Korean agencies would be responsible for enforcing the proposal.  He explained that the US industry 
had expressed concern regarding the provisions re quiring extensive annual reporting of information 
concerning manufacture and import.  He inquired as to the basis for requiring annual reporting of this 
kind, as well as reiterated queries about the poten tial scope of this reporting requirement.  He 
observed that multiple reports did not necessarily  increase safety or reduce risk, but certainly 
increased costs for companies significantly.  He ask ed if Korea had considered other ways to 
streamline and reduce the burden of the required reporting. 
51. The representative of the United States asked whet her applicants or registrants could submit 
data to Korea using the OECD's software, the In ternational Uniform Chemical Information Database
6, 
and whether such submissions would satisfy the regi stration requirements.  He also noted that the 
regulation lacked prioritization of the chemicals subject to the authorization restrictions and 
prohibitions, and he asked whether Korea was c onsidering defining the criteria for prioritizing 
substances.  Also, despite recent proposed change s, Korea's minimum tonnage threshold for pre-
registration and registration of substances of 500 kg w as still much lower than those in other chemical 
regimes, and he sought explanation as to why Korea ha d chosen such a low threshold.  He noted that 
the overall scope of the regulation was very exte nsive.  Industry was expressing a desire for 
exemptions for some categories of chemicals, such as those used solely for research and development, 
and the representative hoped that Korea woul d take these requests into consideration. 
52. Although the US Government believed that inform ation relevant to health and safety should 
not be claimed or otherwise treated as confidentia l business information, both the US Government and 
industry were concerned about protecting such info rmation under the Korean measure. He asked what 
measures Korea would take to protect confidential business information, including trade secrets, while 
registering and evaluating chemical substan ces under this proposal, should it be adopted. 
53. The representative of the European Union welcom ed Korea's efforts to introduce rules on the 
registration and evaluation of chemicals.  The European Union indicated that it supported the 
objective of these rules, namely the protection of human health and the environment, which the EU 
also pursues with its own legislation on chemicals.  The European Union had the following queries on 
the Korean draft regulation.  
                                                      
6 http://iuclid.eu/ . G/TBT/M/54 
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  54. Firstly, the EU noted that many parts of the no tified regulation referred to presidential decrees 
or actions that were still to be adopted to implem ent this regulation. Since these additional rules would 
also contain very substantial criteria, that were necessary to judge the impact of the regulation, the 
European Union was interested to  know when these criteria would be determined and whether WTO 
Members would have an opportunity to comment on them. More generally, the European Union was 
also interested to know more details about the e nvisaged timeline to make the regulation applicable 
and enforceable. 
55. Secondly, the European Union noted that the re gulation requires the evaluation of hazards of 
chemicals and their classification, but did not in clude an explicit reference to the UN Globally 
Harmonized System for the Classification and Labe ling of chemicals (GHS). The European Union 
was therefore interested to know whether Korea had already defined the criteria to be used for the 
evaluation and classification of hazards of chemicals and whether these criteria were in line with those 
of the UN Globally Harmonized System. 
56. Thirdly, the EU was interested to receive confirmation from Korea that data from test 
facilities complying with the OECD principles of Good Laboratory Practice would be accepted under 
the regulation. Finally, the EU stressed that it woul d be open to more in-depth discussions with Korea 
at technical level, also in order to share the e xperience that the European Union had gained from the 
application of its own legislation on chemicals. 
57. The representative of Japan shared the position China and the United States by requesting the 
amount of production and import of the Chemical Substances required to be registered, not be more 
than 0.5t/year but more than 1.0 t/year under the ne w law in order to ensure consistency with other 
countries’ legislation such as EU REACH. More over, the total amount of existing chemicals’ 
production and import in the previous year to be reported is not clearly provided. Japan requests the amount required to be reported be more than 1.0 t/ year to avoid the excessive burden to businesses. 
Japan also requests that the docum ented procedures and instructions in foreign language at least in 
English be developed and published in order for businesses to comply with the new law appropriately 
in a short period. 
58. The representative of Switzerland informed th e Committee that this regulation was been 
examined by experts.  He looked forward to furthe r discussion either bilaterally or in future TBT 
Committee meetings. 
59. The representative of Korea explained the regula tion concerned the registration, evaluation, 
authorization and restriction of new chemicals and existing chemicals that were manufactured in or 
imported to Korea. Similar to the EU's REACH programme.  He said the purpose of the regulation 
was to protect human health and the environment by managing chemical substances according to the 
results of assessment of a chemical's hazard and ri sk.  He reported that the regulation was currently 
under review by the Ministry of Government Legislation. 
60. Korean competent authorities had received comments on the proposed regulation from 
domestic and foreign industry and stakeholders, and had sought to  take these into account. With 
respect to comments from the United States, the European Union, China and Chile, he said the 
Ministry of Environment was preparing responses a nd would provide official replies shortly. After 
taking all the comments into account, he explained that the Ministry of Environment foresaw the review of the proposal during the August 2011 Cabine t meeting, and its subsequent submission to the 
National Assembly in September. 
61. On the specifics, the representativ e stated that the 0.5 ton provision had been selected in order 
to cover 80 per cent of the chemical substances pr oduced in and imported into Korea. He noted that 
the 1.0 ton provision in the EU REACH programme was also set to cover 80 per cent of chemical  G/TBT/M/54 
 Page 13 
 
 
  substances produced in and imported into the EU.  However, he explained that unlike the EU REACH 
programme, the regulation would not apply to all the existing chemicals, but only those chemicals 
announced by decree after the enforcement of the re gulation. The Ministry of Environment had aimed 
at 1 January 2013 as the date of entry into force,  and implementation from 1 January 2014.  With 
regard to comments on harmonization with internati onal standards, the representative of Korea noted 
that the definition of chemical materials in the regulation had been adopted directly from OECD 
documents.   
(iii) France – Loi No. 2010-788:  The National Co mmitment for the Environment (Grenelle 2 
Law) 
62. While the representative of Korea understood Fran ce's desire to protect the environment and 
human life, he expressed concerns about the poten tial negative impact on international trade caused 
by the Grenelle 2 Law. He explained that acco rding to Articles 85 and 228 manufacturers should, 
through labelling, provide information on the amount of carbon emission embodied in products and packaging, and also on the environmental impact throughout the product life cycle, including during the manufacturing, packaging, and transportation and waste stages.  He was concerned that the 
labelling requirements were mandatory.  He noted  that, unlike France, many other countries had 
adopted and implemented carbon labelling regulations on a voluntary  basis.  He called on French 
authorities to consider the fact that carbon labelli ng involved considerable time and cost increase for 
manufacturers and exporters.  
63. In addition, the Korean industry was concer ned about the inclusion of transportation 
emissions in the life-cycle assessment, which wo uld disadvantage products manufactured outside 
France due to emissions associated with long-distan ce transport.  He observed that French consumers 
could choose to purchase less environmentally friendl y products manufactured in France over more 
environmentally-friendly non-French products only b ecause of transportation distance.  He recalled 
that his delegation had requested detailed informa tion from the EU enquiry point about the law and 
notification but had not yet received a reply.  He re iterated his request to French authorities and the 
EU enquiry point to provide further information on detailed technical guidance and the status of the 
one year trial implementation. 
64.  The representative of Argentina noted that Fran ce had not notified the complete text of the 
Grenelle 2 Law in line with the obligations stipulat ed under Article 2.9 of th e TBT Agreement, and he 
requested that they do so. He also sought clarification on a number of questions: 
(a) What would be the implementation timelines of the law, bearing in mind that a pilot 
phase was to begin in July 2011 
(b) Was the law compatible with related Europ ean standards, and how would it relate to 
the current development of a methodology by the European Union on environmental footprints? 
(c) Had affected stakeholders, particularly in developing countries, been consulted during 
the standard preparation phase? 
(d) Would the law apply to both industrial and agricultural products? 
(e) Would the law lead to voluntary or compulsory labelling for carbon footprint and 
environmental footprint? 
(f) What methodology would be used to calcula te the carbon footprint under the law, and 
would emissions from international trans port of products to export markets be G/TBT/M/54 
Page 14  
 
  included in this methodology.  If this was th e case, had the situation of geographically 
affected countries been taken into account, since this would lead to a change in 
competitiveness with respect to French national producers and competitors from 
nearby countries? 
Were any clauses for special and differen tial treatment foreseen for developing 
countries as per Article 12 of the TBT Agreemen t?  In other words, had the needs of 
developing countries been taken into account  and had measures been put in place so 
as not to affect the exports of those developing countries.  Apart from trade, had the needs of developing countries been also ta ken into account with respect to special 
development and finance? Had articles on technical assistance for developing 
countries been included, particularly for small and medium sized enterprises (SMEs) 
located in those countries?  
65. The representative of the European Union no ted that the Grenelle 2 Law included 257 
Articles which provided rules for protec ting the environment in various areas, inter alia , buildings, 
cities, transport, energy, climate, biodiversity, hea lth and waste disposal.  She noted the law had not 
been notified because France had not considered that  it had a significant impact on trade, since the 
articles related to products did not comprise criteri a as such, which still needed  to be specified by 
implementing measures that would be specified at a later stage.    However, any implementing measures containing technical regulations or confor mity assessment procedures would be notified to 
the TBT Committee. 
66. Concerning carbon labelling, the representative expl ained that the initial draft of the law had 
indeed contained a provision aimed at introducing an  obligatory carbon labelling in the future, but this 
provision no longer figured in the final version of  the law. Carbon labelling remained therefore 
voluntary in France for the time being. Instead, Ar ticle 228 of the final law provided for a year-long 
pilot phases to be carried out, so as to gradually inform consumers on details concerning the carbon 
footprint of products, and studies were currently ongoing concerning the methodology for the 
calculation of the carbon footprint.  However, she reite rated that no decision had been taken yet in this 
regard - discussion in the TBT Co mmittee was therefore premature. 
(iv) European Union – Renewable Energy Directive (EU - RED) 
67. The representative of Indonesia expressed con cern regarding the European Union Renewable 
Energy Directive (EU-RED), as Indon esia was one of main suppliers of Crude Palm Oil (CPO) to the 
European Union.  She understood the purpose of the implementation of these regulations was to 
replace the use of petroleum-based fuels with re newable energy fuels in order to reduce vehicle 
emissions containing carbon dioxide (CO 2), and therefore reduce greenhouse gas emissions. She 
noted that the EU-RED required criteria for envir onmentally sustainable biofuel production processes.  
In this regard, she requested clarification from the European Union on a number of issues. 
68. To begin with, she said that Article 17, paragra phs 4 and 5, allowed for the revision of default 
values based on scientific evidence compiled by inde pendent experts at the Joint Research Center 
(JRC).  The representative requested confirmation as to whether default values had already been 
revised, and if not, how long would the revision process take and which procedures would follow, 
including decision-making.  Also, she noted that the EU sustainability scheme provided alternative 
methods, other than the default values, that could be  used to show compliance with the sustainability 
criteria for minimum greenhouse gas savings.  Th e representative asked if the Commission could 
confirm whether this alternative data had been received and accepted, the duration of the process 
following the receipt of submissions, and the decision making process.  The representative of Indonesia understood that the independent experts refe rred to in the Directive were part of the JEC  G/TBT/M/54 
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  Biofuels Programme7 financed by the European Union.  She asked if the Commission would 
include experts from outside the Community in order to ensure independence.  
69. In respect of the biofuel market, she noted that although the Commission had explained that 
the EU-RED would not restrict imports of palm oil,  Indonesia was of the view that the biofuel market 
in Europe was shaped by the EU-RED in terms of  default values and financial support provided and 
that there was no meaningful market outside of the mandatory targets being set for the use of biofuels. 
 In this respect, she asked if the Commission coul d confirm, on the basis of an independent market 
study, that an EU biofuel market existed outside of the market created and shaped by the EU-RED. 
70. She also asked if the Commission could explain,  in accordance with Article 16.4, the number 
of voluntary schemes that had been recognized to de monstrate compliance to the sustainability criteria 
set out.   Furthermore, could information be pr ovided on the duration of the assessment process prior 
to a decision being reached?  In accordance with  Article 16.4, the representative inquired as to 
whether bilateral agreements were being negotiated and/or had been concluded with third countries to 
meet the sustainability criteria.  Finally, accordi ng to Article 19, paragraph 6, the Commission would 
submit a report to the European Parliament and C ouncil reviewing the impact of indirect land-use 
change on greenhouse gas emissions and assessing ways to minimize that impact by 31 December 
2010.  The representative sought further information about the report, and whether it had been made 
public. 
71. The representative of Argentina put on record his delegation's concern with the EU-RED. 
72. The representative of the European Union was aw are of Indonesia's concerns regarding the 
EU-RED and noted that extensive bilateral discussions had been held with Indonesian authorities on 
this issue over the past three years.  Most recently, this issue had been discussed during the visit of EU 
Trade Commissioner Karel de Gucht to Jakarta in May 2011.  She reported that the European Union 
had also started a specific palm oil dialogue with Indonesia, including both Indonesian authorities and 
industry.   
73. It was recalled that the EU had notified the draft Renewable Energy Directive to the TBT 
Committee in July 2008 (G/TBT/N/EEC/200) due to the existence of TBT el ements in Articles 18.2 
and 18.3 of the original proposal.  However, thes e elements had not been retained in the final 
Directive. The concerns expressed by Indonesia rela ted, either directly or indirectly, to the 
sustainability criteria for biofuels outlined in the Directive, which fell outside the scope of the TBT 
Agreement.  Therefore, her delegation considered  that the TBT Committee was not an appropriate 
forum for discussing this issue, or for providing a reply to Indonesia's queries.  However, the EU 
remained open to further bilateral exchan ge with Indonesia in this regard.  
(v) Brazil – ANVISA Enforcement of CATEC Technical Opinions 4, 5, 6 and 7 of 
21 December 2010 
74. The representative of the United States noted that on 21 December 2010 the Câmara Técnica 
de Cosméticos  (CATEC), which he explained was the scientific technical body that advised ANVISA 
on matters of cosmetics regulation, issued four technical opinions with respect to ingredients in 
cosmetics products.  He explained that Techni cal Opinion 4 recommended maximum concentration 
levels for certain forms of Vitamin A in cosmetic  products.  It classified products containing certain 
forms of Vitamin A at a particular risk level fo r purposes of registration and mandated that suppliers 
submit certain tests and evidence of chemical stab ility, and recommended that such products carry 
warning labels. 
                                                      
7 http://ies.jrc.ec.europa.eu/jec-rese arch-collaboration/about-jec.html . G/TBT/M/54 
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  75. The representative of the United States sai d that Technical Opinion 5 recommended 
maximum concentration levels for Urea for certain cosmetic produc ts, and the submission of safety 
tests that, in some cases, would be assessed by ANVISA.  He also noted that certain products 
containing Urea would be classified at risk levels fo r purposes of registration, and that warning labels 
would be made compulsory for all cosmetics produc ts containing this substance.  He noted that 
Technical Opinion 6 recommended maximum concentr ation levels, restrictions, and compulsory 
warning labels for additional substa nces contained in cosmetics.  In addition, Technical Opinion 7 
recommended that Saw Palmetto be banned as an in gredient in personal care products, cosmetics, and 
perfumes.  While not taking a pos ition on the substance of these technical opinions at present, the 
United States was concerned about a lack of transpar ency with respect to the opinions.  He explained 
that although ANVISA was of the view th at these technical opinions were voluntary 
recommendations without any binding legal eff ect, the opinions contained mandatory language, 
including, compulsory warning labels, the requireme nt to submit test results, and provisions that 
products would be classified in a particular way for purposes of registration.  Furthermore, he reported 
that industry representatives had come away from recent meetings with ANVISA with the impression 
that the opinions would, in fact, be enforced in Brazil as binding. 
76. The representative of the United States request ed written clarification from ANVISA on its 
website as to whether the opinions were voluntary or binding. If they were voluntary, he requested that ANVISA correct the language in the opinions that seemed to signal otherwise, which would 
eliminate the uncertainty in the marketplace. If, on the other hand, the opinions were binding, or if 
ANVISA sought to make them binding, whether thr ough developing a measure at  the national level or 
at Mercosur, the representative requested that they be  notified to the WTO as they contained elements 
of technical regulations and conformity assessment  procedures that significantly affected trade. 
Furthermore, he requested an adequate transition period for industry to comply.  Finally, he sought 
any information from the Brazilian delegation as to the legal status of these opinions, and what measures Brazil may take to clarify the situation for the cosmetics industry and for consumers.   
77. The representative of the European Union echoe d the concerns raised by the United States, 
and sought clarification as to whether the techni cal opinions were in any way mandatory.  In other 
words, she asked whether cosm etics not complying with the opinions, in terms of maximum 
concentration or labelling recommendations, would s till be allowed to be sold in Brazil.  If these 
opinions were voluntary, she asked if there were an y plans to make them mandatory, either at the 
national level or at the regional level through a Merc osur technical regulation.  Should they become 
mandatory, the representative reminded Brazil of the obligation to submit a notification to the TBT 
Committee at an early draft stage. 
78. The representative of Brazil responded that the technical opinions in question were issued by 
CATEC, which was a technical committee establis hed in 2004 to advise on issues relating to 
cosmetics.  Such technical opinions had the st atus of recommendations and served as a technical 
scientific reference for ANVISA.  He stressed the fact that they were not binding.  He explained that 
the technical opinions covered substances for whic h there was not yet any specific regulation in 
Brazil, but which could pose health risks.  The representative of Brazil noted that when preparing 
technical opinions, CATEC took into account intern ational references, including the United States 
Food and Drug Administration (FDA), the Cosmetic Ingredient Review8, Health Canada, and the 
European Scientific Committee.  Since the technical opinions from CATEC were not binding, he said 
they could be questioned at any time and that ANVISA was open to receiving scientific data from 
interested parties so that it could better assess th e merits of the technical opinions.  Hence, the 
Brazilian delegation was of the view that CATEC t echnical opinions were not technical regulations, 
given that they were not mandatory.  Therefore the TBT Committee was not the appropriate forum to 
                                                      
8 http://www.cir-safety.org/ .  G/TBT/M/54 
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  discuss them.   However, his delegation remained op en to further bilateral discussion on this issue 
with interested delegations. 
(vi) India – Toys and Toy Products (Compulsory Registration) Order 
79. The representative of the United States noted that  the Indian Ministry of Consumer Affairs, 
Bureau of Indian Standards (BIS), was proposing to issue a new Toys and Toy Products Compulsory 
Registration Order.  While his delegation fully su pported the objectives of protecting health and 
safety, especially children's health and safety as rega rds toys and toy products, he raised a number of 
concerns with the Order.  To begin with, India ha d not notified the Order in draft form to the WTO, 
denying Members and others the opportunity to comment on the process.  The US industry was 
concerned that the new requirements would be ov erly burdensome and potentially duplicative of 
existing requirements.  In particular, the order appeared to mandate a new registration procedure 
requiring the provision of very specific informa tion from production.  The required information 
pertained to each factory's management compositi on, the raw materials used, factory components, 
factory layout, production process, packaging and st orage, details of quality control of staff, and 
information regarding all machinery in the factory,  including the serial numbers for all equipment on 
the factory floor.  He noted that, in addition,  a notification was required whenever a piece of 
equipment was removed from the factory,  even for the purpose of maintenance. 
80. The representative of the United States asked what the rationale was for providing such 
detailed information; his delegati on was concerned about how the conf identiality of this information 
would be ensured, and legitimate commercial inter ested protected.  The representative understood that 
the order as imposed would require that sampling, in spection and test reports be conducted by either a 
BIS recognized laboratory in India, or an overseas laboratory covered by an MRA with BIS.  His 
delegation was not aware of any such MRAs, and th erefore this provision would amount to an in-
country testing requirement.  In this regard, he su ggested the alternative of recognizing test results 
from internationally recognized labs such as thos e that had been accredited by an ILAC MRA 
signatory.  This was the current practice of India's Directorate-General of Foreign Trade, which had a 
notification procedure covering imported toys. 
81. In addition, the US delegation was concerned th at should this Order be adopted, two separate 
Indian measures would cover imported toys wher eas there would only be one regulation covering 
domestic toys.  The representative of the United Stat es inquired why it was necessary for two agencies 
to be regulating imported toys and whether there we re plans for the two ministries to coordinate in 
streamlining the respective requirements so to fac ilitate compliance by industry without sacrificing 
the protection of health and safety. 
82. The representative of the European Union al so expressed concern about the Order and 
requested that it be notified under the TBT Agreemen t in order to allow a more detailed examination 
of the consequences of this proposed change in In dia's conformity assessment regime for toys.  He 
reiterated the concerns expressed by the previous sp eaker that the Order implied a shift to a more 
stringent conformity assessment regime than what was currently in place (supplier's declaration of 
conformity (SDoC)). The new system had the signi ficant limitation of requiring in-country testing, 
compared to the current regime which accepted t est results from foreign independent ILAC accredited 
laboratories.  He also said the system would be c oupled with an onerous registration procedure.  The 
EU representative hoped India would ensure transparen cy if this planned change was implemented, 
and his delegation wished to have an opportunity to  further discuss this matter bilaterally in the 
margins of the TBT Committee meetings. 
83. The representative of Switzerland echoed the con cerns raised by the previous speakers and 
invited India to notify the new regulation to the TBT Committee. G/TBT/M/54 
Page 18  
 
  84. The representative of India reported that the Bureau of Indian Standards (BIS), which 
formulated standards on toy products, was in the process of formulating a standard for the use of 
phthalates in toys.  This standard was currently in the draft stage; it was open for comments from 
Members until 20 June 2011.  Nevertheless, he emphasized that the standard had not been 
operationalized into any sort of technical regula tion.  The Department of Industrial Planning and 
Promotion was contemplating the development of certain regulations based on these BIS standards, 
but they were still in the process of drafting them.  The representative assured all interested parties 
that his delegation would notify the draft technical regulation once it was finalized.  He also noted the 
concerns raised by the US delegation on the deta iled factory information, among other issues, and he 
pledged to revert back to the responsible administra tive ministry while they were still formulating the 
draft Order. 
(vii) India – E-Waste (Management and Hand ling) Rules 2010 (G/TBT/N/IND/41) 
85. The representative of the United States said hi s delegation fully supported the objectives of 
India's Ministry of Environment and Forests in th eir E-waste Management and Handling Rules, which 
sought to protect human health, safety and the environment.  He expressed appreciation for India's 
notification of the measure in response to request s from Members.  He noted that numerous comments 
had been submitted by US companies and industry a ssociations through the Indian enquiry point.  The 
representative expressed further appreciation for India's many significant revisions to the regulation in 
response to the comments received, such as: reduci ng the scope of substances covered from twenty 
down to six, revisions to the de minimis  thresholds, and changes to product scope. 
86. However, the representative of the United St ates raised some additional questions about 
elements of the measure.  The representative said th at certain provisions coul d be overly burdensome, 
work against the stated objectives of the measure and even restrict trade.  For example, he cited a 
provision that required producers to submit detaile d information on the constituents of the equipment 
used in the recycling process, and he questioned the objective behind producers revealing potentially 
proprietary information in this context.  He ob served that not only could this provision jeopardize 
legitimate commercial interests and stifle industrial development, it could also make it more difficult 
for companies to use innova tive substitute materials. 
87. The representative of the United States asked wh ether India planned to provide additional 
guidance with respect to the provision of the regulation that called for producers to provide information on the hazards of improper E-cycling.  Furthermore, he understood that producers were 
responsible for funding and organizing a system to  meet the costs involved in environmentally sound 
management of E-waste from their products.  He noted this requirement could pose challenges for 
Indian, American and third countries' small and medi um-sized enterprises (SMEs).  In this regard, the 
representative asked whether there could be a gene ral fund set up for SMEs so that they could 
collaborate, particularly when they may not have the resources or contacts to set up their own system.  Finally, the US representative recommended that  India increase the three month implementation 
period given that producers would need time to es tablish E-waste collection, handling and recycling 
systems in India.  Also, it would take time for E- cyclers and E-waste handlers to be established and 
approved by Indian authorities.  He urged India to  take these factors into account in evaluating the 
measure further. 
88. The representative of India said the E-waste (Management and Handling) Rules 2010 had 
been notified to the TBT Committee on 4 October 2010, and a 60 day comment period had been 
provided.  He explained that the Rules would enter into force on 1 January 2012, and the reduction in 
the use of hazardous substances (RoHS) would be implemented with effect 1 January 2014.  The 
representative appreciated the constructive suggestions of the US delegate on the draft rules.  He 
agreed that the issue of the SMEs would need to be looked at by Indian regulators in terms of permitting collaborative applications in the context of  the various norms established by these rules.   G/TBT/M/54 
 Page 19 
 
 
  He asked the US delegation, and ot her delegations, if they had and suggestions with regard to the 
specific format of collaboration between SMEs in submission of data.  Finally, he said he would 
forward to capital the suggestion of increasing the implementation period. 
(viii) Kenya – Alcohol Labelling: The Alcoholic Drinks Control (Licensing) Regulations, 2010: 
Legal Notice No. 206: 2010 (G/TBT/N/KEN/ 282) 
89. The representative of Mexico expressed concer n about the Alcoholic Controls Act 2010, 
published by Kenya on 7 December 2010, and notif ied 1 March 2011.  She said Mexico shared 
Kenya's interest in protecting human health , and protecting consumers against misleading 
information.  Mexico also shared Kenya's interest  in disclosing relevant scientific information about 
the consumption of alcohol, establishing programme s for alcohol treatment and rehabilitation, as well 
as adopting measures to eliminate illegal trade in al cohol which affected the health of the world 
population.  Nonetheless, in her delegation's view, th e legislation contained criteria which would give 
rise to unnecessary barriers to trade.  She cited Artic le 32.3, which required that at least two of the 
three warning texts (as specified in Annex 2 of th e notification) take up not less than 30 per cent of 
the total surface of the product.  The represen tative said this requirement was unnecessary for 
achieving the legitimate objective of protecting public  health; in her delegation's view, there were 
more effective mechanisms in the fight ag ainst the excessive consumption of alcohol. 
90. In addition, Article 32.4 established that the comb ination of text or lettering be rotated every 
50 packets of each brand's beverage.  However, the legislation did not e xplain how this rotating 
requirement would be implemented in practice, wh ich would lead to uncertainty in the cost of 
labelling and related logistical details.  Her de legation believed that Kenya could apply a less 
restrictive policy to moderate the consumption of al coholic beverages in its territory.  For example, 
Kenya could use information campaigns  as well as public policies to control the problems of alcohol 
consumption.  In addition, she requested information on studies, including those supported by the Kenyan Government, which justified the imposition of the aforementioned measures. 
91. Furthermore, she said Kenya did not appear to uphold the obligation stemming from Article 
2.9 of the TBT Agreement, since the legislation ente red into force before it had been notified to the 
WTO:  the measure was notified in March 2011 but ha d been enforced in December 2010.  Therefore, 
Members had not had a chance to submit their comment s for consideration prior to the adoption of the 
measure, which she said was important given th e potential economic and trade impacts of the 
measure.  The representative of Mexico therefor e requested that the Kenyan authorities consider 
comments made by the Government of Mexico with r espect to the legislation in question, and provide 
the scientific information upon which they based  their decision to impose these measures.  She 
requested that Kenya comply with the provision of  the TBT Agreement by imposing a less restrictive 
measure to moderate the consumption of alcohol in its country, for example through public policies 
that raise awareness amongst the population of the pr oblems deriving from excessive consumption of 
alcohol. 
92. The representative of the United States reiterated concerns raised by Mexico with respect to 
the size of the warning label in proportion to th e bottle, as well as the rota tion requirement for the 
warning statements.  He enquired as to the rationale  behind the possible inclusion of pictures in the 
alcohol warning statement.  With respect to no tification, the representative asked why the measure 
had been notified under Article 2.10 rather than Ar ticle 2.9 of the TBT Agreement.  His delegation 
had subsequently been able to submit comments, wh ich was appreciated, and he requested a dialogue 
on those comments with the Kenyan authorities.  The representative further requested that the 
implementation period be extended to allow for the major modifications proposed under the new 
requirements, if they did indeed enter into force.   At present, his delegation's understanding was that 
implementation of at least some parts of the measu re had been postponed due to pending legal action.  G/TBT/M/54 
Page 20  
 
  He asked if Kenya could confirm this understanding and, if so, clar ify which sections were postponed, 
and the expected length of the implementation delay.  
93. The representative of the European Union also expressed concerns with the measure, which 
contained technical regulations that had not been  notified under the TBT Agreement.  Her delegation 
had recently taken the opportunity to submit deta iled comments on the above-mentioned notification 
and was awaiting a written reply from Kenya.  Th e representative of the European Union enquired 
whether Kenya had considered less burdensome altern atives to modify drinking behaviour other than 
mandatory health warnings labelling.  The European  Union's experience in this area had demonstrated 
that drinking behaviour needed to be addressed in a holistic manner.  Education and information 
activities seemed to be appropriate means to a ddress the public health objective pursued, and she 
therefore asked Kenya to reconsider this measure.  With respect to the form of labelling information 
provided, she sought confirmation that products would be able to gain market access in Kenya as long 
as the importer added an extra sticker containing the requested warning messages. 
94. The representative of Kenya noted the comments and concerns expressed and said that her 
capital would soon issue written responses. 
(ix) Korea – Amendment to Radio Waves Act 1/2011 (RRA) 
95. The representative of the United States expressed  several concerns with the amendments of 
the Radio Waves Act which put into place new ma rking and labelling and certification requirements 
for a host of information technology products.  First, Korea had not notified the implementing 
regulations of the Radio Waves Act to the WT O for comment.  Although he understood that the 
Korean Communication Commission (KCC) had belate dly opened a comment period on the measure 
from 2 May to 20 May (18 days), he nonetheless hope d that Korea would still notify the measure to 
the WTO, and provide an adequate comment period. 
96. With respect to implementation, the representa tive of the United States noted significant 
confusion amongst industry with respect to what was required by the Act, particularly in terms of 
marking and labelling requirements.  Unfortunate ly, compliance was required by 1 July 2011, and 
importers were required to comply with this dead line in terms of date of importation, while for 
domestic manufacturers, the deadline referred to the date of manufacture.  Given the fact that the 
labelling requirements were still the subject of di scussion, he said this deadline did not provide 
sufficient time for industry to re-label and rep ackage products, and had drastic consequences for 
foreign products which were already in  the pipeline for shipment to Korea. 
97. The representative of the United States understood that industry had requested a two year 
adjustment period.  This would mean that products  that were certified under the previous system 
would be able to continue using prior markings  until January 2013 and he noted that compliance 
periods this long were not unusual in other market s for such complicated and broadly applicable 
requirements.  In addition to a longer adjustment pe riod, he stated that the compliance date needed to 
be based on date of manufacture for both importe d and domestic products.  Industry had raised 
numerous questions with respect to the labelling i ssues and he requested that the KCC work closely 
with industry representatives to resolve these concer ns so to ensure companies understand how to 
comply.   
98. He encouraged the Korean authorities to make the labelling requirements applicable only to 
products meant for retail sale to consumers.  Indeed, his delegation believed that this was in fact the 
intent of the measure; namely, that the measure a pplied only to products meant for retail sale, and not 
to business-to-business sales.  He noted a lack of  written guidelines on this point, and said industry 
had been told that Korean customs would make  a decision on whether labelling was required on a 
case-by-case basis, and this lack of clarity was very disruptive for commerce.  Finally, under the  G/TBT/M/54 
 Page 21 
 
 
  amendments set forth, new electrical safety and certification requirements would enter into force in 
January 2012 and he asked whether non-Korean labora tories would be able to demonstrate that they 
could test and certify to these requirements. 
99. The representative of Korea said that his authorities could postpone implementation no 
longer, given that the requirements in question had originally been notified on 1 July 2009 under the 
Framework Act on National Standards.  He noted in light of the 30 June 2011 implementation 
deadline, that the Korean competent authority ha d provided a very reasonable 2-year adjustment 
interval, which was sufficient for in ternational industry to adjust th eir products and processes.  With 
respect to the different implementation dates for imported and domestic products , he reconfirmed that 
the Radio Research Agency (RRA), which fell u nder the auspices of the KCC, had changed the 
implementation date for imports from the date of  importation to the date of manufacture, which 
therefore applied the same conditions to impor ted and domestic products.  The representative of 
Korea noted that the RRA had visited the United St ates and had held several meetings in order to 
explain the new measures to US companies and related industries.   
(x) Korea- Proposed Cosmetics Labelling and Adve rtisement Guidelines (G/TBT/N/KOR/308); 
KFDA draft Guidelines for Managemen t of Nanomaterials in Cosmetics 
100. The representative of the United States noted that  this trade concern related to three different 
measures.  First, with respect to the Cosmetics Ac t revision, he understood it had been passed at the 
Korean National Assembly Welfare Committee a nd the full vote in the National Assembly was 
currently pending.  He relayed the concerns of US industry with a provision of the Act that would require cosmetics manufacturers to indicate, in  Korean, the product name, company name, batch 
number and expiration date or peri od after opening, on both the primary package and on the labelling 
and the secondary or outer package. 
101. While the US delegation supported the objective of enhancing consumer information, he 
nonetheless raised a number of industry's concerns .  First, the potential costs of the additional 
labelling could be substantial.  S econd, there could be delays at the border while the packages were 
inspected, and he noted that opening the secondary packaging to inspect the primary package could 
damage the product's quality and contents.  In additio n, he said translating the name of the products 
and company into Korean could be problematic, since some US products were known to Korean 
consumers under their English name  (all advertisements were made  using English names).  As a 
result, he suggested the requirement could negativel y impact the image of a product.  However, he 
emphasized that the concern with translation was not  related to directions for product use or safety 
information, but with respect to the brand name.  If all the necessary and detailed information on the 
product, including the ingredients, were already labelled on the secondary packaging his delegation 
believed that it should be sufficient to fulfil Korea's objective. 
102. With respect to the Guideline for Cosmetics Labelling and Advertising, the US representative 
said they set out positive and negative lists of claims that could be made with respect to cosmetics.  
He recalled that US industry had filed comments in late April, and he understood that the Korean 
Food and Drug Administration (KFDA) planned to fi nalize the measure after the National Assembly 
passed the Cosmetics Act.  He noted two particular concerns raised by industry.  First, there were 
already two measures in Korea that covered cosm etics labelling: a Korea Fair Trade Commission 
regulation and the Product Liability Ac t, and he enquired how a third measure would interact with the 
other two should there be instances of overlap. 
103. Second the representative of the United States obser ved that if a company wanted to make a 
claim not found on either list, the procedure for doi ng so was not clear.  For example, he asked 
whether a company could make a claim where the wording was different from that indicated on the 
negative list, or make a claim not mentioned on eith er list.  Moreover, he noted that the negative list G/TBT/M/54 
Page 22  
 
  of claims was very broad and included claims th at were normally accepted around the world, which 
could have a negative trade impact.  For example,  the negative lists included claims on anti-ageing 
properties and claims for hair care products.  While his delegation fully supported Korea's objective of 
ensuring that consumers understand the claims bei ng made, he underscored concerns about proposed 
requirements for the use of foreign languages, and in particular brand names, which the representative 
also mentioned with respect to the Cosmetics Act Revision. 
104. With respect to the KFDA Guidelines for Manage ment of Nanomaterials in Cosmetics, which 
required the labelling of nanomaterials contained in cosmetics products, the representative of the 
United States noted that US industry had sent comments in April.  He asked Korea to confirm that it 
would notify the guidelines to the WTO once draf ting was complete.  The representative expressed 
concern with the requirement to note the presence of  nanomaterials in cosmetics.  In 2007, the US 
Food and Drug Administration Task Force analysed th is precise issue and had determined that the 
scientific evidence did not support a finding that classes of products with nanoscale materials necessarily created greater safety c oncerns than classes of products without nanoscale materials.  The 
task force had indicated there did not appear to be a basis for requiring that a product containing 
nanoscale materials be labelled as such, and did not recommend that FDA require such labelling.  He 
offered to provide copies of the report as backgroun d information.  While labelling of cosmetics to 
include relevant information, such as the conse quences which may result from the use of the product 
under prescribed or customary conditions of use, w as appropriate, he argued that requiring across the 
board labelling when a nanomaterial was present was not necessary, since it provided no useful 
information to the consumer, and was potentially mi sleading as it suggested that the product may be 
different than an equivalent non-nano product in some material way, or was potentially unsafe. 
105. However, the representative of the United States noted that having specific criteria to 
establish whether a material should be considered a nanomaterial within a specific regulatory context 
could be useful where that information was releva nt to the determination of safety or efficacy for 
example.  In this context, he noted that th e Nanomaterials Working Group of the International 
Cooperation on Cosmetics Regulation (ICCR)
9 had identified criteria for determining whether an 
ingredient in cosmetics could be considered a nano material.  He suggested that Korea might consider 
this work in the interest of promoting harmoniza tion.  In addition, his delegation would welcome 
Korean government and industry participation in that forum. 
106. The representative of the European Union supporte d the concerns raised by the United States 
with respect to the Cosmetics Act revision and the KFDA Guideline for Cosmetics Labelling and 
Advertising.  She highlighted concerns about the requirement to indicate the product name and 
company name in Korean on the label of the primar y package.  To comply with this requirement, 
importers would potentially have to open and re-lab el all products destined for the Korean market 
with stickers, which would increase costs and time to market, and could also damage brand image.  
She asked when Korea intended to notify the Cosmet ics Act revision to the TBT Committee which, as 
the United States had said, was already pending before the National Assembly.  She noted the 
importance of providing WTO Members with the opportunity to comment on measures while still in draft form. 
107. With regard to the KFDA Guidelines for Cosm etics Labelling and Adve rtising, containing 
negative and positive claim listing, her delegation was currently in the process of finalizing its 
comments on the TBT notification, and sought certain cl arifications.  She asked Korea to clarify what 
type of documents would be required from producers to  substantiate the claims that they used.  As 
currently elaborated, the draft guidelines simply stated that the methods to be used for the 
substantiation of claims be  "adequate" and "objective", without furt her details.  Second,  with regard to 
                                                      
9"http://www.fda.gov/Cosmetics/InternationalActiv ities/ConferencesMeetingsWorkshops/International
CooperationonCosmeticsRegulationsICCR/default.htm ".  G/TBT/M/54 
 Page 23 
 
 
  the testing requirements, she inquired as to the ra tionale for the substantiation of claims requiring 
certain tests – for instance "in-vivo" testing - wh ich were usually reserved for higher risk products 
such as pharmaceuticals.  Third, she asked Korea to clarify the re lationship between these guidelines 
and the revision of the Cosmetics Act, which also c overed cosmetics labelling.  In general terms, the 
representative of the European Union expressed her delegation's concern with the multitude of rules 
applicable to cosmetics in Korea, which were e ither being developed or had recently been adopted, 
which were contributing to a climate of confus ion and legal uncertainty for economic operators. 
108. The representative of Korea explained that the purpose of the proposed Cosmetic Act was to 
regulate labelling of cosmetics and protect consumers.  He said that the Act was currently being 
reviewed by the National Assembly, and that th e competent authorities had received comments on the 
proposed guidelines from industry and stakeholders  since December 2010.  In addition, a public 
hearing had been held on 16 December 2010.  The Act had been developed based on the idea that 
customers usually threw away the package of cosmetics after they had opened the package for initial 
use.  Therefore, it was deemed important to affi x or print information on the containers or the 
products themselves, such as the brand name, comp any name, importer name, and expiration date, in 
order to ensure that customers continue d to have access to this information. 
109. The Act required that the Korean language be  used along with any other foreign languages, 
and his delegation understood that other countries, such  as the United States, the European Union, and 
Japan had the same requirements in their domestic market.  He noted that the competent Korean 
authorities provided a very reasonable two and a ha lf year interval with a view to allowing 
international industries sufficient time to adjust to the new requirements.  The representative also 
noted that all products manufactured during this gr ace period were allowed to enter into the Korean 
market after the implementation date.    
110. With respect to the Guidelines for Cosmetics Labelling and Adve rtising, he explained that it 
included three lists of claims and expressions, which we re either: (i) Prohibited, (ii) Allowed, or (iii) 
Acceptable under the conditions that the claims and e xpressions were supported by trial and test data.  
He further explained that the methods and standard s included labelling claims and expressions such as 
"can be used on acne-prone skin" or "delays skin ageing".  Regarding the negative list, he reported 
that it was developed on the basis that some expr essions used in advertis ements and labelling of 
cosmetics could cause consumers to mistake them for pharmaceuticals, resulting in adverse outcomes 
associated with the safety and efficacy of products.  Hence, the proposed guidelines were designed to 
ensure appropriate advertisement and labelling of cosmetics, and therefore protect consumers.  
Furthermore, he explained that the guidelines were necessary to provide the cosmetic industry time to 
prepare for an additional upcoming amendment of  the Cosmetics Law which would introduce an 
Advertising Substantiation Policy, currently  under review by the National Assembly.  
111. The representative of Korea noted that the co mpetent authority had received comments on the 
proposed guidelines from industry and stakeholders beginning December 2010, and that a public 
hearing was held on 16 December 2010.  In addition, the competent au thority had also considered the 
regulations of OECD members such as Japan, Au stralia and Canada.  The draft Guidelines for 
Management of Nanomaterials in Cosmetics were  under internal discussion and consultation within 
the KFDA.  Therefore, there were no specific conten ts to notify to the TBT Committee at the current 
stage and his delegation believed it was premature to engage in a discussion of them in the TBT 
Committee.  Once a specific guideline was availabl e it would be notified and a reasonable comment 
period provided.  G/TBT/M/54 
Page 24  
 
  (xi) Mexico- Energy Labelling Measures (Law fo r Sustainable Use of Energy, 28 November 2008; 
Regulation of the Law for Sustainable Use of Energy, 11 September 2009; National Program for Sustainable Use of Energy 2009-2012, 27 November 2009; and Catalogue of equipment and appliances used by manufacturers, import ers, distributors and marketers that require 
mandatory inclusion of energy consumption information, 10 September 2010) 
(G/TBT/N/MEX/214) 
112. The representative of the United States raised  some concerns about Mexico's Energy 
Labelling measures encompassed by:  the Law for Sustainable Use of Energy (28 November 2008); 
Regulation of the Law for Sustainable Use of Energy (11 September 2009); National Program for Sustainable Use of Energy 2009-2012 (27 Nove mber 2009); and the Catalogue of equipment and 
appliances used by manufacturers, importers, distributors and marketers that require mandatory 
inclusion of energy consumption information (10 September 2010).  While the Government of the 
United States and its industry supported Mexico's efforts to raise consumer awareness of energy 
consumption to encourage energy efficiency thr ough a labelling system, concerns were expressed 
about the lack of transparency and the overly bur densome nature of the current Mexican law and 
regulations.   While the representative of the Un ited States understood that the measure had perhaps 
been notified recently, he requested Mexico to ensu re their notification and delay the implementation 
of the new requirements until after the consideration of comments.   
113. On certain substantive issues in  respect of the catalogue, the US delegation noted that the 
scope of the products to be subject ed to energy output labelling listed in  the catalogue was very broad.  
For instance, the United States was not aware of another energy labelling programme covering the 
breadth of products that would include can-openers and other types of devices characterized by very 
low energy use.  Indeed, the actual testing and labelling for such small appliances would probably 
consume more energy than the product itself in actual use.  He asked the repr esentative of Mexico to 
consider narrowing the scope of the products includ ed in the catalogue to reflect those covered by 
other energy-labelling guides.  He also pointed out that some of the concepts like "stand-by mode" 
that appeared in the catalogue probably did not apply to all products.  It was also unclear what the 
proposed label would look like and where on the product it would be placed; this could confuse 
consumers.  The delegate of the United States also  pointed at a lack of clear guidance on the testing 
procedures to be used for the purposes of labelling.  Since different manufacturers of the same product 
could be using different test methods, it could be very difficult for consumers to compare one device 
with another because the numbers on the label would be derived from different testing procedures.  
Moreover, test methods had still not been develope d for many of these products.  Given that these 
methods would be product-specific and take time to  develop, the United States asked Mexico for a 
delay in the implementation and enforcement of  the law, which was set for September 2011.  
Different industry associations, including those of  the electrical, appliance, and information 
technology industries, had submitted comments.  Th ey were working with their counterparts in 
Mexico and willing to work with the Government of  Mexico in order to come up with a workable 
solution.  The delegate of the United States conc luded by asking Mexico whether energy efficiency 
could be part of the on-going North Ameri can harmonization work, as suggested by many 
stakeholders. 
114. The representative of the European Union echoed the concerns raised by the United States.  
While the European Union supported the objective of energy efficiency and environmental protection, 
further clarification regarding the legislation at issue was necessary.  The representative of the 
European Union asked why neither the law for su stainable use of energy, nor the catalogue of 
products subject to energy-labelling requirement had been notified according to Article 2.9.2 of the 
TBT Agreement.  Second, she inquired how the Mexican authorities would ensure that missing relevant and applicable tests for some products w ould not lead to the use of different measurement 
procedures, resulting in different outcomes and pot entially misleading consumers or reducing their 
trust in energy efficiency policy.  Third, it wa s unclear whether the labelling requirements set out  G/TBT/M/54 
 Page 25 
 
 
  would apply to products already placed on the market , including products already distributed to sales 
floors or to warehouses.  If this was the case, this wo uld lead to a logistically burdensome and energy 
consuming re-labelling of  products already placed on the market.  As well as urging Mexico to 
provide a reasonable transitional period, the delegate asked whether the option to apply stickers to the 
external surface of the retail packaging would be a llowed.  Finally, the European Union asked Mexico 
whether and how international standards had been  taken into consideration when developing the 
labelling requirements and tests methods. In addition, the EU noted that a request for clarification had 
also been sent to the Mexican Enquiry Point on 10 June 2011, to which the EU hoped to receive a written reply. 
115. The representative of Japan supported the pos ition of the United States and the European 
Union.  Although Japan recognized the objective of the requirement, including the idea of supplying 
pertinent information to assist customers in sel ecting products with outstanding energy-saving 
performance characteristics, Japan was concerned a bout the above-mentioned measure.  First, the 
catalogue of products targeted would include items for which hardly any effects could be expected 
from the regulation.  Second, the details of the desi gn of the labels to be displayed; the measuring 
methods and other areas remained unclear.  The de legate of Japan was of the view that some 
requirements could be difficult to address by manufac turers.  He also argued that consumers could be 
negatively impacted if they failed to obtain appropr iate information.  Accordingly, implementing the 
system in the proposed format would run the risk of diversifying the content of the label, ultimately generating confusion not only for manufacturers but also consumers.  He stated that Mexico should 
file a TBT notification about these measures in orde r to give Members the opportunity to express 
opinions.  He invited Mexico to narrow down the product scope of the measure and to clarify the 
terms of use and the specific labelling methods.  A period of one year following the official 
announcement of the labelling requirements was suggest ed in order to allow manufacturers, importers 
and other concerned businesses time to prepare, give n the considerable inventories maintained by 
individual companies.   
116. The representative of Argentina stated his country's interest in learning more about how 
exactly the proposed measure would function. 
117. The representative of Mexico confirmed that th e catalogue of equipment was notified to the 
WTO on 15 June 2011(G/TBT/N/MEX/214).  According to the notification, the entry of force of the 
measure was envisaged for 11 September 2011.  In li ne with Article 2.9 of the TBT Agreement and 
on the basis of this notification, a 60-day period for comments would allow all parties concerned to 
comment.  All comments would be taken into account.  The representative of Mexico indicated that a 
Working Group, established in collaboration with the Secretariat of Energy of Mexico, was in charge 
of drafting the measure and was currently considering a ll the criteria, in particular the tests, evidence 
and scope associated with the implementation of th e measure.  In addition, the Woking Group was 
also working closely with industry and the Cham ber of Commerce.  In fact, as part of the 
administrative regulatory procedure, the drafted ve rsion of the catalogue had been submitted for 
public consultation on a website of the Federa l Commission of Regulatory Improvements in August 
2010, allowing the private sector to comment extensively.  
(xii) South Africa – Liquor Products Act of 1989  
118. The representative of the United States expressed  concern with the Liquor Products Act of 
1989, setting out quality and identity standards for spirits  to be marketed in South Africa.  He argued 
that the way South Africa defined the spirits on the basis of alcohol content was at the root of the 
problem.  In particular, he noted that there was a gap in the measure between a “spirit cooler” defined by a maximum alcohol content of 15 per cent and a “liqueur” with a minimum alcohol content of 24 
per cent.  As a consequence, a product characterized  by an alcohol content between 15 and 24 per cent 
could not be marketed in South Africa.   G/TBT/M/54 
Page 26  
 
  119. The representative of the United States explaine d that a US company had been trying to 
market a product with an alcohol content of 17 per cent in South Africa since the beginning of 2009.  
Given the impossibility to change the product form ulation to modify the alcohol content without 
changing the product, this firm had applied to mark et the product both as a spirit cooler and a liqueur, 
but both applications were rejected due to the mi ddle range alcohol content of the product.  The 
delegate of the United States concl uded that this problem was related to the definition of spirits based 
on alcohol content rather than on the raw materials and production process.  He was not aware of any 
health or safety reason explaining why liqueurs coul d not be between 15 and 24 per cent alcohol.  In 
fact, he noted that South Africa made an exception for Amarula, a domestic product containing 17 per 
cent alcohol and sold as a liqueur in many other ma rkets.  According to the representative of the 
United States, this provided evidence that South A frican authorities did not have health or safety 
concerns about this product which also contained 17  percent alcohol and was sold in other markets.  
This raised potential issues of differential treatme nt for foreign and domestic producers of liqueurs.  
For that reason, the representative of the Unite d States asked South Africa whether the liqueur 
definition could be revised to be based on raw materials and production processes rather than on 
alcohol content, or to consider another more trad e-facilitative approach to allow this US company to 
sell its product in the South African market.   
120. Although the company's application had been  discussed bilaterally and the relevant 
documentation had been provided, the company still ha d not received approval or an explanation or  
response from the South African Liquor Products Divi sion of the Department of Agriculture, Forestry 
and Fisheries.  Given that this company had been waiting several years to export its product, the 
representative of the United States asked South Afri ca for a status update on the application and an 
explanation for the undue delay. 
121. The delegate of South Africa noted that, to the extent of his knowledge, no specific 
international standard existed w ith regard to liqueur on which all countries needed to base their 
technical regulation.  Liqueur definitions relied, therefore, on national regul ations which could differ 
from country to country.  In fact, the guidelines and resolutions on wine and all products of vine, 
including grape spirit, provided by the Internati onal Organization for Wine and Vine (OIV), would 
not necessarily apply, because the spirit normally used in liqueurs could be from agricultural origins, 
such as cane, grain or any other vegetable articles cheaper than grape spirit.  The representative of 
South Africa explained that, in general, liqueurs were  usually produced by the maceration of fresh or 
dried fruit, or fruit peels or aromatic plants in a spir it or the adding of flavourings of vegetable origins, 
herbs or extracts thereof to a spirit and adding theret o a sugary syrup and colorants, if applicable.  He 
said that although the OIV was working on a draft resolution proposing 15 per cent minimum alcohol content and no maximum alcohol level for spirit- based liqueurs and a maximum of 100 grams per litre 
of sugar, no guideline or resolution describing a minimum level of alcohol for liqueurs had been 
accepted by the organization or its member countries, including South Africa.   
122. Moreover, the delegate of South Africa explai ned that the Liquor Products Act, which had 
been in place since 1989, was based on the technical  specifications for produc tion of liqueurs set out 
in the Wine, Other Fermented Beverages and Spir its Act which dated back to the 1950s, because the 
liqueurs continued to be produced in that way today.   He confirmed that according to the Act of 1989, 
the minimum alcohol content of liqueurs was set to 24 per cent, without any maximum alcohol requirement.  In line with the national treatment obligation contained in Article 2.1 of the TBT 
Agreement, the minimum requirement of 24 per cent volume of alcohol did not differentiate between 
locally produced or imported liqueurs.  In addition,  the existence of legitimate divergences of taste, 
income, geographical and other factors between count ries were acknowledged in the TBT Agreement.   
123. With regard to Amarula sold in the South A frican market, the representative of South Africa 
explained that it was a wine-based product, classified as an aperitif or cocktail, and did not comply 
with the definition of liqueur.  According to the Liquor Products Act, a cocktail marketed in South  G/TBT/M/54 
 Page 27 
 
 
  Africa was defined as a product produced by the combination of wine with herbs, natural extracts of 
herbs, other flavours of vegetable origin, or extracts thereof, or flavours of nature-identical, egg or a 
dairy product, in order to produce a distinctive tast e and aroma differing from that of wine or a class 
of wine and composed of an alcohol volume betwee n 15 and 23 per cent.  He explained that Amarula 
for the export market complied with the definition of  a cream liqueur, since it was produced to have a 
spirit base.  Since Hpnotiq - the product the United St ates wished to export - could not be considered 
as a wine-based aperitif or cocktail,  or as a cream liqueur since no cream had been included, it could 
not be compared with Amarula.  The US product in question could be sold in the local market only if the exporter was willing to comply with the local re gulation, which would involve either reducing the 
alcohol content to below 15 per cent to meet the spirit definition or raising it above 25 per cent to 
comply with the liqueur definition.  Alternativel y, the US company could adapt the product to an 
Amarula-type beverage by converting it to a wi ne-based product, just like South African producers 
would adjust their products to the regulations of th e importing country.  Finally, he noted that a proper 
evaluation of the product which the United States wished to export was taking a bit more time than expected.  South African regulators were still invest igating the different laws  and options under which 
the product could be accommodated fo r importation into South Africa. 
(xiii) Viet Nam – Conformity assessment procedu res for alcohol, cosmetics, and mobile phones 
(Notice regarding the import of alcohol, cosm etics and mobile phones, No.: 197/TB-BCT (6 
May 2011) and Ministry of Finance No.: 4629/BTC-TCHQ on the importation of spirits and cosmetics (7 April 2011) 
124. The representative of the United States express ed concerns about a series of notices and 
documents issued by the Government of Viet Nam over the last three months with suggestions for 
new conformity assessment procedures requirements for a diverse group of imported products.  He 
referred in particular to the notice on the importation of spirits and cosmetics, which had been issued 
on 7 April 2011 under the Ministry of Finance doc ument no. 4629, and notice no. 197 on the import 
of alcohol, cosmetics and mobile phones, which had b een published by the Ministry of Industry and 
Trade on 6 May 2011.   
125. The representative of the United States explaine d that notice no. 197, apparently establishing 
a quality control procedure requirement through the submission of a quality conformity certificate, had been raised as a priority issue in a letter sen t on 24 May 2011 to the Viet Nam Vice-Minister of 
Industry and Trade from five foreign embassies in Hanoi, including that of the United States.  
According to him, further clarifications regarding the legal status of both documents were necessary.  
In particular, he asked for confirmation whethe r any quality control procedures implemented were 
also applied to domestic producers and if that was the case, what mechanism w as used to ensure that 
local producers undertake the same or comparable procedures.  Th e representative of the United 
States also requested confirmation a bout the entry into effect of notice no. 197, which had been set as 
1 June 2011.   
126. The representative of the United States noted, more generally, that it was unclear why and 
which criteria were used by Viet Nam to select alc ohol, cosmetics and mobile phones to be subject to 
these procedures and not other products.  Since US exporters were still tryi ng to understand how to 
comply with these measures, the re presentative requested a precise description of the goods subject to 
the measures, preferably by indicating the HS cod es.  He also requested clarification on the quality 
control requirements, the nature of the quality conformity certificate and the identity of the authority 
issuing it as well as the relevant standards used to evaluate each product in terms of quality.  It was 
also not clear why the quality control pr ocedures were limited to three ports.   
127. The representative of the United States noted that  none of these measures had been notified to 
the WTO for comment even though the implementation period provided appeared to be less than one 
month after the issuance of the final notice.  Vi et Nam was strongly urged to notify these measures, G/TBT/M/54 
Page 28  
 
  suspend their implementation until the measures were appropriately modified to take into account the 
comments made and provide a reasonable period for supp liers to comply.  He explained that if it was 
the case that no quality control procedures were in place, Viet Nam should clarify it in writing 
through the issuance of another notice.  In such a case, he concluded that there would be no reason to 
restrict the entry to three ports.   
128. The representative of the European Union join ed the delegation of the United States in 
expressing concern about Viet Nam's recent measures to  regulate imports of various products such as 
spirits, cosmetics and mobile phones.  She expl ained that the European Union was one of the 
signatories of the letter mentioned by the United States and sent to the Ministry of Industry and Trade.  
She was looking forward to Viet Nam's replies to  the questions raised by the United States and 
reminded Viet Nam of its obligation to notify dr aft measures to the TBT Committee insofar as they 
contained TBT elements, and to provide for an ad equate implementation pe riod in order to allow 
economic operators to adapt to new requirements. 
129. The representative of Australia shared the concerns of other delegations about both notices 
issued by Viet Nam.  In particular, he expressed concern with the conformity assessment procedures 
set out in document no. 4629, including with r espect to the compliance of  these measures with the 
TBT Agreement.  It was unclear whether the conf ormity assessment procedures would also apply to 
domestic producers and what the basis to identify th e products was.  More specifically on document 
no. 4629, Australia requested further information on the identification of the products, namely alcohol 
and cosmetics, and the nature of the quality ch eck.  In addition, more information about the 
certification of quality conformity, together with the timeline for issuing the certificate, was needed.  
The representative supported the calls requesting Viet  Nam to suspend the measure until clarification 
and adjustment of the measure to the comments pr ovided by trading partne rs.  He concluded by 
explaining that limiting the entry points to the th ree international seaports, as referred to in the 
document, would potentially lead to extra costs of exporting products to Viet Nam by precluding air 
and road traffic as possible transport options.   
130. The representative of New Zealand supported the interventions made by other delegations and 
requested clarification and details regarding the quality conformity certificate requirements both to 
ensure exporters would be able to comply with these requirements and to be assured that Viet Nam 
would take account of its WTO obligations.   
131. The representative of Canada also expressed inte rested in obtaining more information about 
the conformity assessment requirements associated with these notices. 
132. The representative of Viet Nam said that all the comments, concerns and questions raised 
would be sent to capital to get an official reply.  He nevertheless asked that those Members having 
taken the floor send their written comments to Viet Nam's national TBT enquiry point.   
(xiv) Malaysia – Draft Protocol for Halal Meat and Poultry Production ( G/TBT/N/MYS/23)  
133. The delegate of the United States expressed concer n about Malaysia's draft protocol for halal 
meat and poultry products.  While acknowledging Mala ysia's desire to institute a reliable halal 
system, as well as the opportunity provided for comm ent prior to the implementation of the revised 
protocol, he requested Malaysia to take into acc ount the US comments.  He was concerned that the 
protocol would require dedicated halal establishments  and, therefore, requested Malaysia to indicate 
whether the protocol would require an entire supply chai n to be dedicated exclusively to halal.  In this 
regard, he highlighted the fact that sufficient pr ocesses, consistent with th e Codex halal guidelines, 
were already in place in the United States to prev ent any co-mingling of ha lal and non-halal product 
produced in the same establishment, segregated by time and space.  He argued that exclusive 
dedication should not be required as long as a forei gn producer could sufficiently demonstrate that  G/TBT/M/54 
 Page 29 
 
 
  halal and non-halal products had been  completely segregated.  He ur ged Malaysia to adopt a similar 
approach as part of its halal protocol.   
134. The representative of the United States also noted  that food safety and halal were two separate 
issues.  Halal was a religious and processing issue which needed to be audited separately from food 
safety.  Consequently, it was important to ensure th at Malaysia would continue to allow mechanical 
slaughter of both poultry and meat as long as the process would fully allow for the required ritual 
slaughter methods.   
135. The representative of the European Union join ed the United States in expressing concerns 
about the draft Protocol for halal meat and pou ltry production.  She mentioned that comments had 
been sent to Malaysia on 30 May 2011 and her author ities were looking forward to a written reply.  
Several points needed to be clarified.  To begin w ith, she asked if Malaysia had the intention to notify 
the draft protocol to the SPS Committee, given that  beside TBT-related issues, some aspects of the 
notified protocol (among them those related to sl aughtering process and techniques) appeared to be 
covered by the SPS Agreement.   In addition, she no ted that the purpose of the draft Protocol was to 
support the implementation of Malaysian compul sory standard MS 1500 of 2009 on "halal food 
preparation, production, handling and storage, gene ral guidelines", making the standard, in effect, a 
technical regulation; it should, hence, have been notified in accordance with Malaysia's WTO 
transparency obligations. The EU therefore invited Ma laysia to also notify this mandatory standard to 
the WTO, and make it freely available to economic operators.    
136. On a separate point, the representative of the European Union reminded Malaysia of the 
obligation to use international standards as a basis fo r its requirements, and enquired to what extent 
Malaysia had taken into account the relevant inte rnational standards in this area, most notably 
CODEX standards CAC/GL24 and CAC/GL26 of 1997.  Moreover, it was also unclear whether establishments carrying out both halal and non-hala l activities would be eligible for approval, 
provided that a strict separation between halal a nd non-halal products was guaranteed. Furthermore, 
the EU highlighted the importance of implementing the procedures proposed with the greatest 
transparency and objectivity, including, for instance,  by providing a clear indication of the timeline in 
which the inspection of facilities and approval of  foreign products could be expected.  The 
representative of Malaysia was urged to ensure  that its procedures for assessment of halal 
establishments were not more trad e restrictive than necessary to gi ve Malaysian authorities adequate 
confidence that its requirements were met.  In this regard, she was interested to know whether 
Malaysia would also accept inspection results and certificates from the competent authorities of the 
exporting country.  This would facilitate trade, be in  line with international standards and lead to an 
effective use of human resources.  
137. The representative of Argentina also expressed his concern about the notified protocol in 
respect of guidelines for the slaughter, stocking and transportation of halal products, including 
poultry.  In particular, he argued that the requireme nt that establishments had to dedicate exclusively 
to Halal production in order to export to Malaysia would create unnecessary obstacles to trade and be 
more restrictive than necessary.  Malaysia shoul d have considered the Codex guidelines specifying 
the general directives regarding the use of halal meat and labelling.  According to these guidelines, 
halal foods could be prepared and stocked in diffe rent sections or different lines within the same 
building or establishment producing also non-halal products, as long as there was no contact between 
halal and non-halal products.  In a ddition, halal foods could be pro cessed, transported and stocked in 
places which were used for non-halal foods as long as the appropriate cleaning techniques in line with 
the Islamic requirements were observed.  Based on the information received from the Argentinian 
sanitary authorities, the delegate explained that the seven argentine establis hments authorized to 
export to Malaysia were suspended by DVS on November 2010 without receiving any official 
Malaysian communication in this regard.  G/TBT/M/54 
Page 30  
 
  138. The delegate of Brazil thanked the Malaysia n delegation for the opportunity to discuss the 
issue bilaterally and indicated that he was looking forward to receiving answers to written comments 
sent to Malaysia.  
139. The representative of Malaysia thanked all the de legations that had prov ided written questions 
and raised comments regarding the draft protocol for halal meat and poultry production, notified in 
document G/TBT/N/MYS/23.  He explained that tec hnical experts in capital were currently reviewing 
all the comments and questions received.  Written answers to these questions would be provided as 
soon as possible.  In addition, he indicated that bilateral discussion with interested Members would 
continue in order to clarify and resolve this issue. 
(xv) Colombia – Commercial Truck Diesel Emissions Regulation ( Resolution 2604, 24 December 
2009)  
140. The delegate of the United States was concerned about Resolution 2604 issued on 
24 December 2009, which provided mandatory emissions limits for commercial diesel trucks sold in 
Colombia.  He noted that the measure in question had not been notified to the WTO and the domestic 
comment period provided had been approximately 15 days.  Consequently the US industry had not 
been made aware of the opportunity to provide input  into the process for developing the measure.  He 
urged Colombia to notify the measure to the WT O, take comments into account, and revise the 
measure before its entry into force, scheduled in 2013.   
141. The representative of the United States noted th at although he supporte d Colombia's objective 
to lower emissions from commercial diesel trucks fo r health and environmental reasons, he explained 
that according to the US industry the diesel fuel cu rrently available in Colombia was not compatible 
with the US Environmental Protection Agency's 2010 emission standards (EPA 2010), which was what Colombia would be requiring for US trucks s ubject to this measure as of 2013.  In particular, 
engines built to meet the EPA 2010 or even the EPA 2007 rules required ultra-low sulphur diesel fuel with a sulphur content of less than 15 parts/milli on, while the sulphur content in Colombian diesel 
fuel was at least 50 parts/million.  According to in dustry, the high sulphur content of this magnitude 
would clog the diesel particulate filters installed on tr ucks that met those two EPA sets of rules.  Since 
the appropriate fuel was not available in Colombia and would not be for at least several years, the 
delegate concluded that this measure would eff ectively bar US diesel trucks from the Colombian 
market, representing a very large market for US supp liers.  He suggested that requiring diesel trucks 
sold in Colombia to meet an earlier version of  the EPA rules, such as the EPA 2004, would be 
workable for US industry and still help  reduce emissions in Colombia.   
142. The representative of Colombia noted that a bila teral meeting would be held to resolve the 
concerns expressed by the United States.   
2. Previously raised concerns 
(i) European Union – Regulation on the Regist ration, Evaluation and Authorization of 
Chemicals (REACH) (G/TBT/N/EEC/52 and Adds .1-6; Add.3/Rev.1; G/TBT/N/EEC/295 and 
Add.1; G/TBT/N/EEC/297; G/TBT/N/EEC/333-6) 
143. The representative of India expressed concer n about the definition of Small and Medium 
sized enterprises (SMEs) in the Eur opean Union for purposes of lower registration costs citing that the 
European definition of SMEs did not account for labour  intensive industries such as those in India.  
He noted that the criteria using both annual turnove r and the number of employees in the organisation 
would be unfair since it would place Indian SMEs in the large enterprises category.  He urged the 
European Union to reconsider the definition of the SMEs within REACH.    G/TBT/M/54 
 Page 31 
 
 
  144. He also stressed the high burden placed on SMEs as a result of the creation of the Substance 
Information Exchange Fora (SIEFs ) and consortia beyond the purview of regulatory control and with 
potential to be dominated by European industry.  He highlighted some specific concerns with SIEFs, such as a high joining fee, penalties associated with joining the consortia late, annual maintenance fee, 
non-uniform rules of different consortia, high fee fo r lead registrants, refusal by Members to accept 
participants, prohibitive cost of letter of acceptance et c.  Moreover, there was a lack of transparency in 
the functioning of the Steering Committee, responsib le for establishing the rules of the consortia 
particularly in the areas of cost sharing and determination of fees.  
145. He added that as data costs became extremely high, the letter of access (LoA) had emerged as 
a default option for SMEs and that the European c onsortia were encouraging and advising upfront in 
favour of the use of the LoA as opposed to data sharing as a more practical solution while providing 
inadequate information on the comparison of the co sts entailed in either option, or the basis for 
determining LoA costs or the cost-sharing.  He und erscored that the real concern was not with the 
costs themselves but with the practices involved in the determination of these costs.   
146. The representative of India acknowledged th e principles set forth in ECHA Guidance 
Document on Data Sharing, for example, the need  to agree on terms and conditions for cost-sharing 
and data between registrants and data holders at an early stage in the data sharing process.  However, 
he noted that the principles were not followed re gularly and that the consortia tended to inform 
registrants of the costs of the LoA at the last minute, allowing them little option but to pay.  He 
requested, therefore, that the European Union consid er the application of some special and differential 
treatment for data sharing in the consortia set-up.  
147. Furthermore, the representative of India asked fo r clarification on the logic of registration of 
monomers under REACH given that the life cycle of the monomer ended once it was reacted into a 
polymer.  He noted that monomers were normally stable within the polymers and did not pose any 
separate risks.  He also highlighted that the information on monomers did not provide any conclusions on the risks posed by the polymers. India was also  concerned about the registration of the entire 
tonnage of the substance in an article, even if not all of it (less than 100 per cent) of the substance was 
intended for release upon use of the article.  This increased the tonnage band for registration, and 
made it harder for the registrant.  
148. On animal testing he noted that the principles of REACH emphasized avoidance of animal 
testing and stressed the sharing of animal testing da ta.  Additionally, the Joint Research Centre (JRC), 
he said, had found that in the best-case scenario, REACH would require testing of 2.1 million to 3.1 
million animals by 2018.  He noted, however, that  the scientific magazine "Nature" had recently 
reported that generation of REACH data could require testing of up to 54 million animals and cost 
approximately €10 billion, within the next ten y ears; hence, the estimates by the JRC were under-
estimations.  This, he noted, would make the le gislation unfeasible and raised concerns over the 
economic and regulatory rationale of REACH.  He al so noted that the high costs of data-sharing in 
SIEFs made a case for computer simulation of chemi cal testing, and requested the European Union to 
consider the option. 
149. The representative of Argentina reiterated concerns  with the complexity of REACH due to its 
various phases of implementation and underscored that  the regulation, in its current form, was an 
unnecessary obstacle to trade.  He pointed out the un certainty and lack of transparency that result 
from the complexity of REACH as well as the frequent amendments to the legislation, noting that the 
regulation had been amended 19 times, six modifica tions of which had been introduced within the 
past four months.  He mentioned Regulation no. 143/2011, which added si x substances to Annex 14 
of REACH, that referred to substances requiring marketing and use approval from ECHA ; Corrigendum of Regulation no. 143/ 2011 modifying the time-frame for the procedure; Regulation No. 
252/2011 modifying Annex 1 to adjust classificati on criteria in other provisions of Regulation G/TBT/M/54 
Page 32  
 
  1272/2008 on Classification, Labelling and Packag ing of Substances and Mixtures; Regulation 
253/2011 modifying Annex 13 containing the criteria to identify the persistent bio-accumulative and 
toxic substances as well as very persistent and very bio-accumulative substances; Regulation No. 
366/2011 modifying Annex 17 - Restrictions to th e manufacturing, marketing and use of specific 
substances, mixtures and dangerous articles, intr oducing new provisions on th e particular substance 
called aklomide; and Regulation No. 494/2011 modify ing Annex 17 as well - restrictions to the 
manufacturing, marketing and use of specific substa nces, mixtures and dangerous articles, banning as 
from 2012, cadmium in jewellery, plastics and weldi ng bars.  The European Union referred to its 
explanatory guidelines trying to facilitate the understanding of REACH amendments, but as these 
guidelines were constantly updated, the exporters faced scarce predictability and transparency in their 
commercial operations.  
150. Argentina was also concerned about any new m odifications and amendments that would be 
brought about by the general review of REACH,  which would be conducte d on 1 June 2012 by the 
European Commission in accordance with paragraph 6 of Article 138 of the Regulation.  He noted 
that this would add to the costs to enterprises of  hiring or contracting services of consultants.  
Additionally, he highl ighted the required cost of designating an Only Representative (OR) in order to 
be able to accede to the European market, a cost which was not born e by European producers, as well 
as the administrative costs for procedures required for the registration of each substance which 
together made the situation worse for SMEs.  
151. Currently, the reduction of rates for SMEs that  REACH allowed were still quite restrictive 
and this reduction was offset by the above mentioned indirect costs which SMEs would have to face.  
He underscored the need, therefore, for the Europ ean Union to enhance the transparency of the 
REACH implementation process, to reduce continuous modifications to the re gulations and to reduce 
the costs of registrations for non-European SMEs  allowing them to align with and compete with 
European companies in line with the national treatme nt principle. Of course, Argentina supported the 
objective of protection of health and the environmen t - but there was a need to ensure that REACH 
did not continue to pose an unnecessary obstacle to tr ade.  In the absence of a solution a large number 
of companies would be left out of  the European chemicals market.  
152. The representative of Canada shared concerns raised by India and reiterated the need for 
information on the measures taken by the European Un ion to ensure that membership to SIEFs would 
not be unduly or arbitrarily restricted.  He expressed concern with REACH impacting the 
competitiveness of SMEs on the European market.  He  also asked what meas ures the European Union 
was taking to ensure that provisions related to substances in articles were implemented uniformly 
across its member States. It was also important that compliance with the measures would not be overly burdensome for industry.   
153. The representative of the United States reitera ted its support for the objective of protecting 
human health and the environment but continued to  express concerns with REACH, noting that the 
European Union had yet to address several trade-rela ted concerns with the regulation that have been 
raised repeatedly, such as the OR concern, or the m onomers and polymers issue.  He also raised a new 
issue with the OR provision of REACH and the process for authorization.  He indicated that Article 
62.2 of REACH did not expressly list ORs as possible applicants for authorization, leaving it unclear as to whether an OR would be allowed to submit an application for a REACH authorization.  He 
noted that if that was not the case and ORs could not apply, each importer of a substance would have 
to apply for authorization.  This would adversely impact foreign manufacturers since they would need 
to submit multiple applications as they would tend to use multiple importers.  On the other hand, he 
noted, European producers of substances would only need to submit one application.  He asked the 
European Union to clarify how it would resolve that issue.  He also highli ghted that the issue was 
particularly bothersome for SMEs since they w ould not have European operations and therefore 
would have to resort to the OR solution as the de facto  option.  He also mentioned that the United  G/TBT/M/54 
 Page 33 
 
 
  States hoped to discuss the issue bilaterally with  the European Union through a new chemicals 
dialogue initiated in 2010.  
154. The representative of China shared concerns of other Members on the subject.  He also 
mentioned that China was awaiting the response of  the European Union to the question of the 
unreasonable cost sharing mechanism, as well as the hi gh costs - issues that had been raised at the 
previous meeting of the Committee. He underscored that the European Union explanation of a number 
of successful registrations did no t constitute justification.  
155. The representatives of Australia, Cuba, Philippi nes, and Thailand, echoed the concerns 
expressed by other Members - in particular with re spect to the complexity of the regulation and its 
potential adverse impact on SMEs.   
156. The representative of the European Union noted that the matter raised by the United States 
(on the possibility for ORs to apply for authoriza tion) was under discussion in Brussels and no answer 
could yet be provided in the TBT Committee.  She al so noted that since most other comments were 
reiterations of previous concerns that had been answered, she would focus on recent developments on 
REACH, connected with the issues raised.  
157. On the subject of the functioning of SIEFs, she noted that the European Commission and 
ECHA would continue their efforts to help industr y and would provide as much guidance as possible. 
However, she noted that, as had already been in dicated on several occasions, it would be up to 
industry to organize itself within the SIEFs, and neither the Commission nor ECHA could interfere.  
She also noted that a Directors' contact group, chai red by the European Commission, had been created 
to facilitate contact with industry to understa nd concerns regarding SIEFs and informed the 
Membership that the mandate of the group had been extended to enable it to tackle issues which were 
relevant for the second registration deadline in 2013 .  She indicated that the group would continue 
working on outstanding issues to find solutions.  
158. With respect to abuses discovered in the SIEFs, these needed to be forwarded to ECHA where 
it would be determined if a response was necessar y and whether it was possible to intervene.   
159. On the issue of requirements on substances in articles, she noted that the guidance on the 
requirements for substances in articles had been  updated and had been published on 1 April 2011.  
However, she confirmed that there was no change  in the Commission's position on the subject.  In 
addition, Article 7, paragraph 2 of REACH was applicable since 1 June 2011 and ECHA had already 
received their first notifications for articles. 
160. With respect to enforcement, it remained to be seen whether EU Member States would 
interpret Article 7 differently than as explained in  the guidelines. As previously explained, the 
European Court of Justice was the institution that  had the final decision on the interpretation of the 
REACH Regulation.   
161. On the issue of the "one-ton" presence criteria fo r substances in articles, instead of the amount 
that was released from the article, –as well as the rationale for the registration of monomers in 
polymers, the EU referred to its previous  explanations in the TBT Committee.  
162. Regarding the definition of SMEs, the represen tative of the European Union said that the 
issue had already been discussed and the definition of the SME was laid down in a European Union 
Recommendation No 2003/361/EC and that definition was used not just for the purposes of REACH, 
but in all legislation and policies within the European Union.   She noted that, given that, it would be impossible to take into account all definitions of th ird countries, as it could not be ensured that this 
would not result in discrimination between EU an d third countries' industries. Therefore the SME G/TBT/M/54 
Page 34  
 
  definition of the European Union would apply to all SMEs, irrespective of their origin, adding that the 
number of employees was an important criterion for th e definition of SMEs in the European Union as 
well. 
163. Regarding the changes to REACH, quoted by Argentina as proof of its complexity, the 
representative of the European Un ion noted that the amendments per se  were not indicative of 
complexity - they had been foreseen from the be ginning.  She explained that REACH had several 
steps and, subsequent to the adoption of REACH,  many substances still had to be identified, and 
certain annexes to the regulation needed to be filled in. This was a normal process which resulted 
from the implementation of REACH.  The same was true of the guidance documents, which were also 
updated due to the progress of various stages of RE ACH, and in order to clarify certain questions, 
such as those raised in the interventions of WTO Members in the TBT Committee. .  ECHA would 
therefore continue to update the guidance documen ts in 2011, in order to help industry submit 
registration dossiers and comply with REACH.  
164. With reference to the draft Commission regulation amending REACH Annex XVII (CMR 
substances) the representative of the European Union informed that the draft had been revised after 
discussions in the legislative procedure, and that a new draft had been sent to the WTO Secretariat 
and would be available soon un der G/TBT/N/EEC/297/Rev.1.  She invited written comments from 
interested delegations, and informed that a peri od of 60 days had been allowed for comments.  
(ii) European Union – Directive 2002/95/EC on the Restriction of the Use of certain Hazardous 
Substances in Electrical and Electronic Equipm ent (RoHS) and Directive 2002/96/EC on 
Waste Electrical and Electronic Equipm ent (WEEE) (G/TBT/N/EEC/247, Add.1 and 
G/TBT/Notif.00/310, Corr.1) 
165. The representative of China expr essed concern about the use of  certain hazardous substances 
in electrical and electronic equipment.  He requested information on the status of implementation of 
RoHS (it was implemented in 2003) and on how the European Union monitored the state of compliance of enterprises.  He also requested clarification on the conformity assessment procedure 
after RoHS and how it conducted market surveillan ce and government supervision and if there was 
any difference between the procedures of different  European Union member States.  He also 
requested further information on the RoHS since th e introduction of the CE marking and asked if the 
testing standard was IEC 62321-2008 and if a new cat egory of electrical and electronic equipment, 
not covered in previous re gulations, had been added to  Annex 1.  Furthermore, he requested details on 
the other equipment mentioned in the category.  Th e representative of Chin a also asked about the 
treatment of national mutual recognition of RoHS testing results.   
166. The representative of Korea acknowledged the adoption of the directive without a priority list 
in line with Korea's request to remove the list.  He  noted, however, that Korean industry continued to 
be concerned about the revised directive, in partic ular, with reference to the adoption of homogenous 
material test methods.  He argued that according to  Korean industry estimates the cost of additional 
tests and certification was expected to be large a nd this would translate into higher production costs 
and be passed on the consumers.  He noted, ther efore, that this would make the directive 
unnecessarily burdensome in proportion to its objective.  He requested the European Union to reduce 
the burden on companies, particularly on SMEs in th e spare parts industry.  Further, he requested the 
European Union to extend the date of implementa tion to allow industries an  adequate adjustment 
period.  
167. The representative of the European Union provi ded delegations with an update on the status 
of the recast of RoHS indicating that, as had been  outlined at the previous TBT Committee meeting, 
the European Parliament had adopted a first re ading position on the proposal of the European 
Commission on 24 November 2010.  She also said that the European Union had notified the document  G/TBT/M/54 
 Page 35 
 
 
  as an addendum to the original TBT notificati on EEC/247 on 21 March, a nd had provided detailed 
explanations of the European Parliament's proposed  changes in both the addendum to the notification 
as well as to the European Union intervention durin g the previous TBT Committee meeting.  In the 
interest of time, she referred Members to the minutes of the previous TBT Committee Meeting, for 
details.  
168. The European Parliament, the Council, and the Commission had worked together to achieve a 
first reading agreement on the draft Directive. Th e Directive had been formally adopted by the 
European Council on 27 May 2011 with the agr eement of the Commission.  The Directive was 
expected to be published in the Official Journal in June or July 2011; it would enter into force 
immediately after publication.  She also indicated th at the Directive would have to be transposed by 
all European Union Member States into national law within 18 months.  With respect to Korea's 
comments, she noted that her delegation had discussed  the issue bilaterally with Korea and that she 
hoped that the explanations provided had helped alleviate Korean concerns.  
(iii) India – Pneumatic tyres and tubes for autom otive vehicles (G/TBT/N/IND/20 and Add.1; 
G/TBT/N/IND/40 and Rev.1) 
169. The representative of the European Union was disappointed about the non-postponement of 
the entry into force of the quality order on pneuma tic tyres and tubes for au tomotive vehicles despite 
significant outstanding concerns on the compatibility  of the measure and the BIS license procedure 
with the TBT Agreement.  She recalled that at  the previous TBT Committee meeting, India had 
informed Members that the Indian Bureau of Sta ndards (BIS) was reviewing the requirement that the 
IS marking could only be used on tyres exported to India and not on those that were sold outside 
India.  She indicated that the requirement w as unnecessarily burdensome and was not based on a 
legitimate objective: it obliged manufacturers to produce tyres specifically for the Indian market.  She 
requested an update on the developments on the su bject and on whether paragraph 6.3 of the BIS 
Agreement would be omitted, as had been request ed by Japan in the previous Meeting.  
170. In addition the European Union continued to be  concerned about the method of calculation of 
royalty fees on the basis of the total number of ty res produced and marked with the IS marking and 
not on the basis of the total number of IS marked tyres de facto imported into India.  This, she said, 
increased the cost of exporting tyres to India.  Sh e also underscored that th e issue was even more 
serious since producers were charged with a marking fee calculated per tyre marked.  She noted that 
the European Union recognized that the requirement al so applied to Indian producers but also stressed 
that the difference in the fees was beyond what would be necessary for the conformity assessment 
costs and contributed to the impression that India was using the measure to discourage imports of 
tyres.  Furthermore, she expressed dissatisfacti on at the continued bottl enecks created by the 
laboratories accredited to conduct relevant testing no ting that it hindered exports of tyres to India.  
She urged India to resolve the issue, for example, by accepting tests from international ILAC 
accredited laboratories at least until the lack of  adequate facilities in India was resolved.  
171. The representative of Korea acknowledged the fact that India had already extended the 
implementation period of the measure twice but noted that certain Korean tyre manufacturers 
continued to experience severe delays in factory inspections.  He noted that the issue was one of 
frequent changes in schedules of Indian inspectors resu lting in delays in payment.  This, he noted, had 
disrupted export plans to India.  He urged I ndia to accelerate the process and to provide detailed 
explanations of the situation.   
172. The representative of Japan expressed concerns over the mandatory certification system for 
automobile tyres in India and said that Japan ha d discussed the concern in detail, both at the TBT 
Committee meetings as well as bilaterally with I ndia.  He acknowledged the fact that India had 
postponed the implementation of the Directive in line with concerns raised.  He also informed the G/TBT/M/54 
Page 36  
 
  WTO Members that in light of continued concerns, the Ministry of Economy, Trade and Industry of 
Japan and the Japanese Automobile Tyre Manufactur ers' Association Inc. had visited the Indian 
Ministry of Commerce and Industry Department of Industrial Policy and Promotion, the Ministry of 
Consumer Affairs, Food and Public Distribution Depa rtment of Consumer Affairs and the Bureau for 
Indian Standards in early May, to request a post ponement of the implementation of the measure.  He 
expressed regret over the fact that the Indian gove rnment still went ahead with implementation.   
173. Highlighting specific problems with the measure, he noted that one of the areas of concern 
was the capacity of the certification authority.  Certain tyre manufacturers had been unable to receive 
factory certification in spite of having applied for it with the Bureau of Indian Standards (BIS).  In 
particular, he mentioned issues with the increased tyre size, subject to mandatory certification since 
May 2010, noting that as a result, tyre manufacturers who had applied for factory certification in June 
2010 had not fully acquired the certification.  Additiona lly, he noted that the addition of certified tyre 
sizes to the factory certificates had not been completed by the date of implementation.  As a result of the circumstances thus created, Japanese companies ha d been forced to suspend exports to India, as 
well as further sales of stocks in India.  He under scored that the measure was a technical barrier to 
trade.  
174. He referred to Article 2.12 of the TBT Agre ement noting that the Decision of the TBT 
Committee which provided for an implementation peri od greater than six months.  However, he noted 
that the six month period was not inflexible and in  a situation where the capacity for certification was 
lacking, the preparation period needed to be set with  flexibility.  He urged the Indian Government for 
retroactive withdrawal of the enforcement and fo r the implementation to be postponed by a minimum 
of six months.   
175. The representative of India noted that the meas ure had already entered into force in May 
2011.  He also underscored that the original intent  of notification to the Committee was made in 2006, 
informing industry and exporters of the intent of  the Indian Government to institutionalize the 
certification system.  Additionally, he noted that the notification had been made in 2010, allowing 
until May 2011 before the entry into force of the me asure and that this time was sufficient, and more 
than stipulated by the TBT Agreement or Deci sions of the TBT Committee pertaining to the 
Agreement.  He therefore noted that the concern over inadequate time allowed for adjustment was not 
reasonable.  He referred to a communication by the Indian Department of Industrial Policy and 
Promotion, listing the types of tyres exempt from th e marking requirements under the regulation that 
could be imported by original e quivalent manufacturers for the replacement market.  He noted that 
this move would facilitate imports within the purview of the measure.  
176. He noted that India had had bilateral discussi on with the European Union and Japan on the 
subject and noted that a majority of the applicati ons for certification for tyre manufacturers had been 
cleared.  The remaining were pending only because of inadequate information or pending fee 
payments, which were being sought from the co mpanies, or in one particular case, a pending 
inspection to Japan - which had not been conducted in light of the circumstances in Japan.  He said 
that the government was attempting to ensure reso lution of all issues and requested specific details 
from Korea so that those concerns could be pursued by  the Ministry.  On the subject of Article 6.3 of 
the BIS Agreement, raised by th e European Union, he mentioned that the amendment would require 
legislative modifications and that the government w as exploring the legal options available to amend 
the article in question, and resolve the issues ra ised by the European Union.  Finally, while his 
government believed that the marking fee was reasonable it would look into the matter.     G/TBT/M/54 
 Page 37 
 
 
  (iv) European Union – Regulation on Classificati on, Labelling and Packaging of Substances and 
Mixtures (ATPs and CLP) (G/TBT/N/EEC /151 and Adds.1-2; G/TBT/N/EEC/212 and 
Adds.1-3; G/TBT/N/EEC/163 and Adds.1-3, Add.1/Corr.1) 
177. The representative of Canada reiterated Canada 's concerns about the European Union's 
classification of nickel-containing substances.  He acknowledged the opinion on the subject, dated 
March 2011, issued by the European Court of Justice.   He reminded the European Union to take into 
account the potential negative impact of classifica tion exercises not based on sound and transparent 
science.  He urged the European Union to ensure  that the measure did not become an unnecessary 
obstacle to trade.  
178. The representative of Turkey reiterated her count ry's concern with the classification upgrades 
and downstream impacts, noting that Turkey had raised these concerns several times at Committee 
meetings.  She requested further information from the European Union on future plans, if any, with 
reference to the existence of new scientific evidence.   She recalled that the European Union had, in 
the previous meeting, confirmed the receipt of a st udy by Turkey, in China,  in a boron mine.  She 
urged the European Union to amend its regulati on in line with the concerns raised.    
179. The representatives of Australia, Cuba, Dominican  Republic and Thailand reiterated concerns 
voiced on the subject at previous meetings and urge d the European Union to consider those concerns. 
The representative of Thailand stressed the importance of ensuring that the substance classification 
was based on indisputable scientific evidence.  Cuba, in turn, reiterated concerns about the inadequate 
extrapolation of the classification of nickel components and the lack of adequate scientific data justifying the need for the measure. 
180. The representative of the European Union took note of the concerns raised on the 
classification of nickel and nickel compounds in the 30th and 31st ATP and said that the European 
Union had already furnished Members with long r esponses to the issues in writing, as well as orally, 
over several Committee meetings.  She invited dele gations to refer to the minutes of those past 
meetings for details.  She also recalled that accord ing to the CLP regulation, the initiative to change 
the classification lay with European Union Memb er States and that any revision could only be 
undertaken if a Member State submitted a proposal to ECHA.  Once the proposal had been submitted 
and if the Commission found that the change in the classification was appropriate, it would prepare 
the decision to amend Annex VI of the CLP regula tion and introduce the modification without further 
delay.  She therefore recommended interested delega tions to present any new scientific data to one or 
more of the European Union Member States in order to trigger the process of submitting a proposal to 
modify the classification of borate compounds.  She also noted that the European Union had not, as 
yet, received any such requests from a third country or industry.  With regard to the study conducted 
in China, mentioned by Turkey, she recalled the EU statement in the previous Committee meeting, 
namely that this study should be submitted to one or more of the European Union Member States.   
(v) Canada – Compositional requirements for cheese (G/TBT/N/CAN/203 and Add.1) 
181. The representative of New Zealand repeated his delegation's concerns about Canada's 
compositional cheese standards and requested  Canada  to confirm that these cheese standards, as per 
the above-mentioned notification and the relevant addendum were in compliance with the principles 
laid out in the TBT Agreement.  She noted that the standards were inconsistent  with Codex standards, 
indicating that Codex standards did not specify restrictions on the sourcing of milk proteins for use in the manufacture of cheese; she asked Canada to explain why it had used more restrictive standards.   
She also commented on the fact that Canadian da iry farmers had continued to lobby the Canadian 
Government for a standard on yoghurt.  She expresse d concerns that any standard on the composition 
of yoghurt would also be inconsiste nt with Codex standards and urged Canada to adhere to the Codex 
standards for any future decisions on federal dairy regulations and standards for yoghurt.  G/TBT/M/54 
Page 38  
 
  182. The representative of Australia expressed con tinued concern with the compositional cheese 
requirements imposed by Canada and on the access to milk protein concentrates and also voiced 
concern about any future measure on yoghurt or other such products.  
183. The representative of Canada noted that his delegations had alread y accounted for both 
international standards and comments made by Members during the notification period.  He 
commented that Canada had not initiated any process  to establish standards for yoghurt or other dairy 
products.  He also mentioned that in light of continued concerns from New Zealand and Australia 
these could perhaps be discussed bilaterally.    
(vi) India – Drugs and Cosmetics Rules 2007 (G/TBT/N/IND/33) 
184. The representative of the European Union e xpressed continued concerns about the Indian 
order on the registration procedures for imported cosm etic products, which had entered into force on 
1 April 2011.  She acknowledged that some concerns raised by the European Union in 2008 had been 
taken into account by the Indian Government but noted, once again, that a notification system as opposed to a registration and authorisation system might  have been less trade restrictive.    She also 
noted that the Indian authorities were yet to provi de a justification for the differing demands on the 
validity period of the cosmetics certificates for im ported and domestic products.  She urged the Indian 
Government to confirm that ade quate action would be taken to en sure that the validity period of 
certificates for imported products would also be rai sed to five years, as for domestic products, from 
the current three years for imported products.  Furthe rmore, she requested Indian authorities to ensure 
that the certificates were issued within a period of two months, at a minimum, and that the tests conducted in the country of origin, attesting complia nce with international co smetics standards were 
also accepted.  She also stressed the importance of allowing for produc ts to be packaged and labelled 
in bonded warehouses before being placed on the Indian  market as an alternative to labelling in the 
country of origin.  
185. The representative of the United States reiterat ed previous concerns, in particular with 
reference to the difference in the validity pe riod of the certificates for domestic and imported 
products.   He asked the Indian dele gation to explain the difference in validity periods - or to bring the 
two periods at par with each other.   He also re quested India to allow producers of cosmetic products 
to conduct the required testing in the country of origin in accordance with internationally recognized 
testing procedures.  Additionally, he raised concerns  about over-labelling and use of stickers.  He also 
noted that US industry had expressed concerns over a host of other issues including placement of import registration numbers, and other technical issu es - these concerns had been submitted in January 
2011.  He echoed the interest of industry to engage in  dialogue with Indian officials to allow them to 
understand how best to comply with the regulation, and to discuss the appropriate transition period.  
This was important as the current effective date  was October 2011 and there were still several 
unresolved issues including the fact that the final regulation had not yet been published.   
186.  The representative of India noted that Indi a's transparency obligations within the TBT 
Agreement had not been violated since the draft on the introduction of the new system had been 
provided in 2007, and the measure would be implem ented on 1 October 2011.  On the subject of the 
differential time periods, he explained that the di fference existed in light of the rigorous licensing 
procedures and inspections carried out on domestic  products in comparison with imported products, 
adding that the validity for all imported goods, both drugs and cosmetics would be three years.  He 
also said that the concern would be forwarded to the regulators, in any case, for them to consider.  He 
acknowledged US concerns and said that India was considering setting up a technical level meeting 
with the United States to engage in a discussion.  He  said that the EU suggestions with respect to 
warehouses was a new issue and would be forwarded to Indian regulators for them to consider.  G/TBT/M/54 
 Page 39 
 
 
  (vii) Colombia – Draft Decree Establishing Provisions to Promote the Use of Biofuels 
(G/TBT/N/COL/96 and Adds.1-5 and Add.4/Rev.1) 
187. The representative of the European Union acknowledged the notification from Colombia 
dated 8 June 2011, on the new draft modifying D ecree No. 2629 Establishing Provisions to Promote 
the Use of Biofuels.  She noted that the Eur opean Union was in the process of analysing the 
notification.  As preliminary comments, she said th at the European Union welcomed the modification 
of the draft that allowed conventional vehicles to use ethanol blends within a range of E8 to E10, as of 
entry into force of the new decree.  Neverthele ss she also observed that as per Article 2, the 
Colombian authorities could modify as of 1 January 2013 the amount of ethanol in fuel, at any time.  She reminded Colombia of Article 2.12 of the TB T Agreement and requested that they provide a 
reasonable period of time between the publication and entry into force of any such modification.  She 
also reminded Colombia that any such modifi cation would have to be notified under the TBT 
Agreement.  She also noted that parts of the wr itten comments sent on 30 May 2011 on the previous 
notified version of the measure continued to remain  relevant to the new draft as well. She expressed 
particular concern over the fact that not all ethanol  blends would be available in Colombia in the 
future, or at least not in the entire territory.  Sh e also requested information on when the technical 
regulations regarding the quality of fuel would be defined - also with respect to diesel.   
188. The representative of Japan shared concerns ra ised by the European Union and welcomed the 
new E8 to E12 regulation expected to enter in to force on 1 January 2012.  He was, however, 
concerned about the fact that relevant Colombia n ministries would hold the authority to increase the 
biofuel regulation label for use in automobiles through administrative procedures.  He reiterated 
concerns raised previously and requested the Co lombian Government to take these into account.   
189. The representative of Argentina asked Colombia to identify the scope of products covered by 
the Draft Decree.  
190. The representative of Colombia noted that Colo mbia had complied with all the transparency 
requirements on the draft decree, notified under G/TB T/N/COL/96/Add.4.  He informed delegations 
that Colombia had accounted for Members' comment s and included these into the draft decree - the 
final draft had been notified under G/TBT/N/COL/96/Add.5, which was available for comments from 8 June 2011 until 30 August 2011.  He also informed delegations that Colombia had entertained in 
bilateral discussions with both Japan  and the European Union.    
(viii) European Communities – Accreditation and market su rveillance relating to the marketing of 
products (G/TBT/N/EEC/152) 
191. The representative of Korea reiterated concerns  with the above-mentioned notification noting 
that in spite of having raised the concern sev eral times, Korea had yet to receive satisfactory 
responses.  He was primarily concerned about  the potential impact on recognition of non-EU 
accreditation bodies under the ILAC-MRA and the IAF-MLA and on acceptance of conformity 
assessment procedures conducted by laboratories accred ited by non-EU accreditation bodies that were 
Members of the ILAC and IAF 
192. The representative of the United States also e xpressed continued concerns with Regulation 
765 that applied to all sectors and required eac h member State to appoint a single national 
accreditation body to operate as a public, not-fo r-profit entity to accredit conformity assessment 
bodies in the EU, thereby prohibiting competition between national accreditation bodies of member States.  He was also of the view that the criteria used were in excess of those used by the ILAC and 
IAF and the European Commission had recognized th at attestations of conformity issued under 
accreditation by non-EU accreditation bodies could be considered as reliable as those issued under the G/TBT/M/54 
Page 40  
 
  accreditation of the European Cooperation for Accreditation (EA)
10 MLA signatory.   He raised 
questions about the necessity of the additional crit eria and noted that th is could undermine the 
international accreditation system under the ILAC MRA and IAF MLA and disrupt imports from the United States to the European Union.   
193. The representative of the United States asked for updates from the European Union on the on-
going discussions between the EA and ILAC on th e relationship between Regulation 765 and the 
standards set out in standard ISO/IEC 17011:2004  as well as the supplementary requirements and 
guidance from ILAC and IAF.   He encouraged the European Union to issue written clarification on 
how the EA would cooperate with non-Eu ropean Union accreditation bodies.   
194. The representatives of Australia and Thailand shared concerns raised by previous speakers 
and expressed the hope that the European Uni on would provide clear, written guidance on the 
consistency of the regulation with  the ILAC IAF requirements.   
195. The representative of the European Union noted that the concerns raised were not new and 
referred in that respect to comments made by his de legation at previous meetings of the Committee.  
He informed delegations that the peer evaluation of EA by IAF and ILAC was in progress and a final 
report was expected to be submitted to the meeti ng of the multilateral arrangements operated by ILAC 
and IAF scheduled to be held in Bangkok in Novemb er 2011.  He also referred to the activity report 
submitted by the EA to its general assembly held on 25-26 May 2011 in Berlin for a more general 
update on the current priority areas for EA.  The report was available to the public on the EA 
website11   
(ix) Thailand – Health warnings for al coholic beverages (G/TBT/N/THA/332) 
196. The representatives of Australia, Chile, the Eu ropean Union, Mexico, New Zealand and the 
United States acknowledged consideration of comme nts provided and requested a further update from 
Thailand on the review of the draft legislation.   
197.  The representative of Thailand noted that the Ministry of Public Health had set up a new 
subcommittee assigned to study the impact of the re gulation on alcoholic beverages, the scope of 
which would also include the regulation on health  warnings under the said notification.  Members 
would be kept informed. 
(x) United States – Hazardous Materials: Transportation of Lithium Batteries 
(G/TBT/N/USA/518) 
198. The representative of the European Union requested  an update on the state of play of the 
proposed requirements on the transport of lith ium batteries, which were over and above the 
requirements agreed upon in the UN Recommendations  on the Transport of Dangerous Goods and the 
Technical Instructions on the Safe Transport of Da ngerous Goods of the International Civil Aviation 
Organization (ICAO).  The EU remained concerned by  the US unilateral appro ach to the issue. She 
expressed agreement with previous remarks from the United States to the effect that since the issue 
was already being dealt with in the ICAO and UNECE - the international standardizing bodies on 
international civil aviation - it need not have been brought to the WTO TBT Committee.  She 
reiterated her delegation's position that the safe tran sport of lithium batteries had been discussed in 
these international bodies and that the proposals made by the United States to lay down requirements 
additional to those agreed upon internationally had al ready been rejected by the technical experts of 
                                                      
10 http://www.european-accreditation.org . 
11 "http://www.european-accreditation. org/content/communi cation/EA_Updates/EA_Activity_Report-
MAY_2011.pdf" .  G/TBT/M/54 
 Page 41 
 
 
  those bodies, which were not just European Union experts, as previous statements of the United States 
in the Committee had implied. She underscored that  the experts had expressed the opinion that the 
agreed upon standards were sufficient, particularly  since there was no accident data available on cases 
where such standards had been respected. She invite d the United States to provide scientific data to 
dispute this to ICAO and UNECE, in which case the technical experts would be willing to look into 
this issue once more, and possibly revise the standa rds if necessary – however, no such sufficient data 
had yet been provided. She urged the United States  to apply the agreed standards and refrain from 
unilateral requirements which would impose a dditional burdens on economic operators.  
199. The representative of Korea said that the most ef fective means of securing safer transportation 
of lithium-ion batteries was to ensure harmonization and compliance with international standards and 
regulations, such as those of the ICAO.   He not ed that the UN and ICAO requirements had been 
discussed, adopted, and used by several countries after much testing and review of scientific evidence.  
It was also his delegation's understanding that di scussions in the US Senate and the House of 
Representatives was on-going, and he requested the United States provide an update on the current 
situation and the future prospects of the discussion.  If the PHMSA12 chose not to adopt existing UN 
and ICAO regulations for transportation of lithium ba tteries, he urged that there be an exemption for 
lithium-based secondary cells (lithium-ion, lithium-polymer etc.) which were shipped at no more than 50 per cent of the charge.  He re-emphasised that according to reports referred to by the Notice of 
Proposed Rule Making (NPRM), the severity of the result of an internal short-circuit was strongly 
affected by the state of charge; fires had a minimal impact on bulk packaged lithium ion cells with less than 50 per cent charge.   
200. The representative of Japan said that while Jap an understood the importance of maintaining 
security of transportation, Japan was concerned a bout the restrictions on transportation of lithium 
batteries by the United States, not just from th e point of view of consistency with the UN 
Recommendations, and the ICAO Technical Instructions , but also from the perspective of the impact 
on trade.  He noted that Japan had continuously claimed consistency with the UN Recommendations 
and the ICAO Technical Instructions .  The delegation of Japan was of the view that some products did 
not need to be included in the regulation where th eir inclusion was not necessary for safety purposes.  
He requested the United States, therefore, to exem pt lithium-ion batteries with low state of charge 
(SOC).  He also noted that the final rule wa s expected to be released on 31 August 2011, and 
requested that the final rule take into account  all opposing views expressed by governments, and 
private entities.  Furthermore, he referred to th e PHMSA website that was considering new proposed 
regulations, the impact of which was expected to be significant.  However, Japan had not received 
detailed information on this matter and requested the United States for such information.   
201. The representative of China also reiterated concer ns previously stated and made particular 
reference to the use of international standards in domestic technical regulati ons, citing Article 2.4 of 
the TBT Agreement as well as the TBT Committee D ecision on Principles for the Development of 
International Standards.  He reminded the United States that consensus was not the only criteria to 
determine if a standard was relevant in the TBT cont ext.  He cited the Appellate Body report in the 
EC-Sardines dispute13 which had upheld the conclusion of the Panel that even if an international 
standard was not adopted by consensus it could still constitute a relevant inte rnational standard under 
Article 2.4 of the TBT Agreement.   Therefore, he  urged the United States to review its position on 
the use of international standards in the current context, and adopt measures to base its regulations on 
the transportation of lithium batteries on relevant existing international standards, in this case the 
ICAO and the UNECE  
                                                      
12 http://www.phmsa.dot.gov/ . 
13 WT/DS231/AB/R. G/TBT/M/54 
Page 42  
 
  202. The representative of the United States informed  the Committee that there was no change in 
status since the previous meeting and that he did not have any information on the timing for the 
release of a final measure.  He noted that the United States would keep Members updated once he had 
the information on any change in status.  He al so said that the United States had received comments 
both in support of the measure, as well as against it,  and thus it would be impossible to agree with all 
the comments.  He mentioned that the United St ates would make every effort to account for all 
comments, based on the evidence on reco rd in shaping the final measure.   He also said he was unable 
to comment on the legislative developments at pres ent, but that the United States was monitoring the 
situation and would provide updates when available.    
203. Regarding the absence of accident data, he noted that one of the other issues involved in the 
proposal was whether small batteries, not covered by  the ICAO technical instructions, could combust 
aboard an aircraft and potentially bring the aircraft  down, which no one has disputed.  He referred to 
the comment from the European Union and said that th e United States did not have to wait for such an 
event to happen before determining to regulat e - and that the TBT Agreement should not be 
interpreted in such a manner.  There were other i ssues besides accident data which US regulators were 
looking into to ensure the safety of aircrafts.  On the subject of international standards and in 
reference to discussions in past meetings of the Committee on procedural deficiencies in the 
development process, he expressed the hope that  the ICAO and UNECE would take adequate 
measures to address the systemic deficiencies in the technical committees where relevant documents 
were being developed.   He noted that United Stat es regulators did participate in the work of those 
committees and would like to, as far as possible, u se the results.  He noted , however, that in the 
current situation the requirements had essentially b een unilaterally decided upon by the European 
Union member States as a majority in the technical  committee, raising questions about the consensus 
principle.  He also highlighted that the Secretar iat could determine which Members could participate 
and which could not and had in the past denied at least one WTO Member permission to participate in 
the work so the process was not ope n to all WTO Members.  In add ition, he noted that there were 
clearly issues of conformity with the WTO Committee Decision (on international standards) and, in 
any case, neither body was mentioned in the TBT Agre ement.  He said that the United States was of 
the opinion that if the appropriate process had been  followed there might have been an international 
standard that everyone could use.   
204. The representative of the European Union noted  that, since the United States was repeating 
the argument that the ICAO or UNECE recommenda tions were taken with the dominance of the 
European Union Member States, she felt it necessar y to inform delegations that both bodies were 
composed of much more than just European Un ion Member States. The ICAO was a specialized 
agency of the UN for civil aviation, whose mandate was to foster the safe and organized development 
of international air transport, including by adop ting standards and guidelines on air navigation. It had 
190 contracting states, including developing countries.   She also referred to the Council of ICAO on 
Air Navigation Issues, which was the body responsible  for the development of technical standards and 
other provisions on air navigation.   She said that  the body was composed of 15 experts with the 
appropriate qualifications and expe rience in aviation to allow them to be a member of the body; 
however, they were nominated by the contracti ng states and appointed by the Council and were 
expected to function as independent experts, and not as representatives of their countries.   
Additionally, referring to the UN recommendation on the transport of dangerous goods of the United 
Nations Economic and Social Council (ECOSOC), she noted that the ECOSOC had 55 members, 
including several African and Asian countries   
(xi) Brazil – Alcoholic Beverages (G/TBT/N/BRA/348) 
205. The representative of the European Union, Mexi co and the United States requested an update 
on the status of the comments submitted to the public consultation and in response to the TBT 
notification, which Brazil had mentioned in the prev ious meeting.  They also requested information  G/TBT/M/54 
 Page 43 
 
 
  on when the new draft proposal would be made ava ilable.  The representative of the United States 
hoped to engage in a technical discussion with experts on both sides. 
206. The representative of Brazil informed delegates that there had been no new development on 
the issues since the previous TBT Committee meeting;  the draft legislation was still under analysis by 
Brazilian regulators, and that there was no forecast  on the publication of a final regulation on the 
subject.  He indicated that comments received from Members were being considered by regulators.  
On the substantive concerns he referred Member s to the minutes of the previous meetings.  
(xii) Turkey – New Conformity Assessment Procedures for Pharmaceuticals ( Circular issued by the 
Directorate General of Drugs and Pharmacy of the Ministry of Health re: "Important Announcement regarding GMP Certificates") 
207. The representative of the European Union reitera ted concerns with the Turkish regulation on 
good manufacturing practices (GMP) requirements for pharmaceuticals, which entered into force on 1 
March 2010.  She noted that to obtain the EU GM P certificates, EU manufacturers were inspected by 
competent authorities within the Eu ropean Union Member States to ensure compliance with GMP.  
Furthermore, she noted that Turkey had not provi ded any indication on whether specific problems had 
been found with EU GMP certified products on its mark et.  Therefore, she urged Turkey to recognise 
EU GMP certificates and standards without need for additional administrative requirements.  
208. The representative of the United States expr essed continued concerns with Turkey's 
conformity assessment procedures for pharmaceutical  imports and requested Turkey to adopt 
measures to restore market access for high quality ph armaceuticals.  He expressed concerns on behalf 
of industry in the United States on the mounting b acklog of goods awaiting approvals, noting that it 
was a concern, not just for companies, but also for patients in Tu rkey who used those 
pharmaceuticals.  He also underscored that the meas ure had never been notified and urged Turkey to 
give high priority to innovative drug applications providing new medicinal therapies to Turkish patients, and process registration files submitted be fore the measure went into force under the old 
regime, noting that the measure should not apply retroactively.  He also proposed technical 
discussions with Turkey on the subject, noting that a delegation from Turkey was expected to visit 
Washington later in the month.    
209. The representative of Turkey noted that the reasons for the measure on GMP certification of 
pharmaceuticals had already been explained at prev ious Committee meetings; he recalled that the 
Ministry of Health had been conducting GMP inspections since 1995, in accordance with GMP 
guidelines for pharmaceuticals and in compliance with th e relevant guidelines of the WHO.   He also 
mentioned that until March 2010, GMP certificates of  other countries, along with those provided by 
the Ministry of Health were accepted - however automatic acceptance was seen as posing a serious 
threat to human health in the ab sence of relevant background information.  The Ministry, he noted, 
had the legitimate right to conduct GMP inspections  for the protection of human health and human 
life.  In addition, he noted that thus far no issu es had been reported with the implementation of the 
regulation; it had run smoothly w ith all applications being processed immediately by the Ministry, 
provided the related files were complete.  He unde rscored that since Sept ember 2010 until May 2011, 
the Ministry of Health had inspected 38 manuf acturing facilities, 34 manufacturing sites, and 236 
products had received GMP certificates.  Further, 62  manufacturing sites were under inspection.    
210. Regarding the processing of GMP inspections, he not ed that currently the Ministry of Health 
had applied a classification system based on the therapeutic priorities of the pharmaceuticals, 
determined according to scientific criteria - this w as in line with public health concerns.   On the 
subject of the processing of registration files submitte d prior to 1 March 2010, he said that the request 
had, in line with previous prac tice, been brought to Turkish cour ts recently and he did not deem it G/TBT/M/54 
Page 44  
 
  appropriate for to comment before the case wa s decided upon.  As implementation continued, 
remaining issues would also be resolved.  
(xiii) European Union - Directive 2004/24/EC on Traditional Herbal Medicinal Products 
211. The representative of China referred to Article 16C of the Directive which suggested that a 
medical product had to be used through a period of at least 30 years preceding the date of application, 
including 15 years within the European Union.   He asked about the opinion of the European Union 
on traditional Chinese medicines (TCM) which had been is use for thousands of years but had been in 
use for less than 15 years within  the Community.  He noted that for such TCM products, which had 
entered the Community market post 1996 would not be  able to prove that they were safe medicinal 
products since they have not been used in the Eu ropean Union for 15 years,  since the transitional 
period elapsed on 1 May 2011.  He was concerned th at this might be a violation of the National 
Treatment principle.    
212. Referring to sub-clause 2 of Article 2, he noted  that the competent authorities would apply the 
provisions of the Directive within seven years once it had entered into force.  He mentioned that the 
United Kingdom and other concerned countries had a nnounced a plan to terminate the import and 
wholesale of TCM finished products from 1 May 2011.  He underscored that trade in TCM goods 
between China and the European Union had in creased tremendously by 101.8 per cent between 
January and April 2011.  The representative said th at the EU had communicated to his delegation 
bilaterally that only one enterprise, or one count ry, had successfully met all the requirements of the 
Directive.  He therefore questioned whether the Directive effectively ba nned traditional herbal 
medicines from outside the EU market.  He also said that seven years was too short a period and 
proposed that the European Union extend the time till 30 April 2019.  He also referred to the fact that 
registered TCM products were required to pass th e EU GMP certification, before they could be 
distributed.   He recommended that since the Eur opean Union was a PIC/S (Pharmaceutical Inspection 
Convention and Pharmaceutical Inspection Co- operation Scheme) member, the European Union 
should consider the possibility to accredit TCM ente rprises that already had EU GMP certification 
from PIC/S members.   He requested the Europ ean Union to check accredited TCM enterprises that 
already had the GMP certification with Australia, a PIC/S member. 
213. He also mentioned that according to the Sino-European Union Working Group 
Pharmaceutical Meeting held on 19 May 2011, where DG Sanco proposed to the SFDA that all 
Chinese made active pharmaceutical ingredients (A PIs) exported to the European Union should 
comply with Chinese GMP standards for APIs.  In hi s view, as per international practice, it should be 
the European Union importers that shouldere d the responsibility of inspection.     
214. The representative of India expressed support for China's statement and referred to minutes of 
the previous meeting where India had made a strong statement. On the subject of the notification, he 
mentioned that the measure, although already in force,  had not been notified to the WTO.  He also 
mentioned that the 15 years of use on medicinal produc ts rule, which China had raised as a concern, 
also concerned India in that it excluded many pr oducts, including herbal medicinal products, from the 
regulation.  He also said that the scope of produc ts which were of mineral and animal origin was not 
clear since Ayurveda, Siddha and Unani products we re covered under the regulation.  He asked for a 
status update from the European Union in this rega rd.   He also mentioned that India had already 
made a request for a simplified application dossi er for the registration of traditional Ayurveda 
products as well as the acceptance of the Indian m onograph as an authentic source of information for 
traditional use evidence in assessing applications for registration.   
215. The representative of the European Union menti oned that they had had bilateral discussions 
on the issue several times and referred Members to minutes of previous meetings where the issue had 
been discussed.  She highlighted that all medi cinal products, including herbal medicinal products  G/TBT/M/54 
 Page 45 
 
 
  required a marketing authorization to be placed on the European market, since 1965, based on 
pharmaceutical, clinical and pre-clinical data.  Sh e also highlighted that since traditional herbal 
medicinal products had particular characteristics by virtue of their longer tradition of use, the European Union took this into account and had introduced a lighter, simpler and less costly registration procedure for them via Directive 2004/24/EC.  The Directive, she noted, allowed 
registration of traditional herbal medicinal produc ts without the requirement of safety tests and 
clinical trials required under the full marketing author isation procedure.  She also underscored that in 
order to benefit from the simplified procedure th e applicant was required to provide sufficient 
evidence of medicinal use of the product over a pe riod of a minimum of 30 years, including 15 years 
in the European Union.  She also said that monographs from India, China or any other country, 
submitted as part of the application dossier we re assessed as any other bibliographical evidence 
submitted with the application.   On the subject of  the 15 years of use in the European Union, she 
noted that the requirement allowed for sufficient monitoring of side effects of the products and 
increasing confidence in its safety in the absence of t ests and trials.   She also confirmed that for 
products for which the 15 years use in the Europe an Union could not be demonstrated, but which 
were in any case eligible for the simplified procedure, Directive 2004/24/EC allowed proving the 
safety of the products by other means to be asse ssed by the Committee for Herbal Medicinal Products 
of the European Medicines Agency (EMA).   
216. On the subject of herbal substances, the represen tative of the European Union said that they 
could be used for manufacture of food or medicines.  However, herbal products that did not fulfil the 
definition of medicinal products did not fall within th e scope of registration.   She also said that an 
herbal product would be considered a medicinal produc t when it had the properties to treat or prevent 
disease in human beings, or where it had pharmacol ogical, immunological or metabolic action.  She 
said that deciding on a case-by-case basis on whether an herbal product fulfilled the definition of a 
medicinal product was the responsibility of the nationa l authorities.  She also highlighted that the 
majority of medicinal products with a sufficien tly long tradition of use were based on herbal 
substances.  Therefore, she noted, it would be appropriate to limit the scope of the simplified 
registration to herbal medicinal products, as a first step.  However, she also noted that the Directive allowed for the presence of vitamins or minerals in  the herbal medicinal products as long as action of 
the vitamins and minerals in the product was ancillary to that of the herbal active ingredients.   She 
also said that traditional herbal medicinal products that were designed or intended for use under the 
supervision of a medical practitioner for diagnos tic purposes or for prescription or monitoring of 
treatment were excluded from the scope of the Di rective 2004/24/EC.  She noted that those products 
demanded the granting of marketing authorization si nce the greater risk or the need for medical 
supervision did not allow for the waiver of the re quirement for preclinical and clinical data.   
217. In addition, the representative of the Eur opean Union said that the Common Technical 
Document (CTD) was an internationally agreed form at to avoid delays in submitting applications to 
the different International Conference on Harmonizat ion of Technical Requirements for Registration 
of Pharmaceuticals for Human Use (ICH) regions.  Th is had facilitated inform ation exchange between 
regulatory authorities for medicinal products.  She reminded India and China that the 2004 Directive 
foresaw a long transition period of seven years fo r manufacturers to submit registration requests to 
relevant authorities for their products.  The Directive was currently in force. 
(xiv) Colombia – Shelf life for milk powder (G/TBT/N/COL/67/Add.3) 
218. The representative of the European Union expr essed continued concerns with the Decree 
adopted by Colombia in the previous year on re quirements imposed on imported milk powder to have 
a shelf life of a minimum of 12 months, six more than what had previously been required.  She 
expressed concern that the extension of the peri od could affect exports of milk powder from the 
European Union to Colombia.  She also reiterated the request made at the previous meeting of the G/TBT/M/54 
Page 46  
 
  Committee, to Colombia, to clarify the risk the authorities sought to address by extending the required 
shelf life of milk powder.   
219. The representative of Colombia reiterated statements made at other meetings of the 
Committee, noting that the draft resolution modifyin g Article 50 of Decree 617 modified by the first 
Article of Decree 1673 dated 2010, on requirement s on powdered milk, had been notified to the 
Committee in January 2011.  He noted that the proposal  had stated that the shelf life of the product at 
the time of entry into the country needed also to ha ve the date of manufacture.  She mentioned that on 
27 January 2011, a document (G/TBT/N/COL/67 Add. 3) had been submitted to the Committee and a 
period for comments was allowed until 19 April 2011, la ter extended to 19 May 2011.  He noted that 
he did not have further update on the measure an d that Colombia had not received any specific 
requests from the European Union on the subject.  He requested that the European submit their 
comments in writing so that they could be responded to.   
(xv) China – Regulations of the PRC on Certifica tion and Accreditation (promulgated by Decree 
No. 390 of the State Council of the PRC on 3 September 2003) 
220. The representative of the United States expressed  continued concern about the long-running 
issue of the Chinese Government not recognizing competent conformity assessment bodies located 
outside China so that U.S. suppliers could more easily demonstrate compliance of products from the 
United States with Chinese certification requirement s.  Because the CCC requirements covered 20 per 
cent of exports from the United States to China, Ch ina’s failure to recognize such bodies negatively 
impacted trade flows from the United States to Chin a.  He noted that the only bodies allowed to 
conduct conformity assessment procedures were Chinese bodies with no presence outside China, 
thereby forcing companies from the United States to  organize funds and travel for Chinese inspectors 
to conduct premarket inspections at the manufac turers' location, submit to subsequent annual 
inspections and to pay for their products to be certified in China.   
221. A solution to the issue needed to be found.  The United States found it increasingly difficult 
to comprehend why China was unable to monito r conformity assessment bodies outside Chinese 
territory, particularly since US regulators had consistently recognized numerous conformity 
assessment bodies in China.  For example, the U. S. Occupational Safety and Health Administration 
had recognized several sites as part of its programme in China, and  the CPSC14 had already 
recognized 104 conformity assessment bodies in Chin a, including joint ventures with government 
laboratories.  He noted that regulators in the Unite d States had developed procedures and criteria, such 
as auditing and inspections as well as other proce dures, to ensure that Chinese bodies met criteria 
when they were recognized and continued to meet th em on an on-going basis.  He said that China was 
free to do the same.  He also mentioned that US  regulators were conducting this recognition in the 
absence of an MRA and noted that China should do the same.  In the even t that the issue was 
technical, he noted that the United States would be willing to organize technical discussions and experience-sharing on the subject to fi nd a quick resolution to the issue 
222. The representative of China noted that the re gulations on certification and accreditation for 
the People's Republic of China had been adopted by the State Council on 3 September 2003, and had 
entered into force on 1 November 2003.  The objec tives of the regulations were in compliance with 
the objectives of the WTO Agreement preventing d eceptive practice, protecting human health and 
safety, animal or plant life or health, or the envi ronment. On the subject of the foreign assessment 
bodies under the CCC scheme, he noted that China was involved in mutual recognition, both 
multilaterally and bilaterally.  He said that as part  of the multilateral framewo rk, China was a member 
of the IECEE/CB scheme, as well as the ILAC MRA and accepted test reports from the CB testing laboratories of other countries within the IECEE/CB scheme. Additionally, he noted that in 2009 
                                                      
14 http://www.cpsc.gov/ .  G/TBT/M/54 
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  more than 3,000 test reports from foreign laboratories were accepted by China, including test reports 
issued by the UL15, a US conformity assessment body.  China had concluded over 40 bilateral 
cooperative documents with over 20 countries in the area and certification bodies from other countries 
undertook part of CCC certification work, via coope ration with domestic CCC certification bodies.  
Moreover, he assured delegations that CCC cert ification could also be conducted by foreign 
certification bodies as part of an inter-governmental MRA within which the ILAC MRA was a key 
technical basis for mutual recognition be tween China and other countries.   
(xvi) Korea – KS C IEC61646:2007 Standard for Thin-film Solar Panels 
223. The representative of the European Union remain ed concerned about the Korean standard for 
thin-film solar panels which preven ted certain types of thin-filmed solar panels from being tested or 
certified, acting as a de facto  market access ban for such technolog y due to the fact that they would 
not qualify for government incentive schemes.  She al so noted that the European Union had received 
information that Korean authorities had been enc ouraging investment and research and development 
activities in these technologies such as in copper-indium  gallium selenium (CIGS) solar panels, which 
undermined the Korean argument that such technolog y posed a threat to the environment.   She 
requested an update from Korea on the study on an environmental impact of thin-film solar panels, 
other than amorphous silicon (A-Si) solar panels, and the expected timeline for the completion of this 
on-going study.   
224. The representative of the United States shared th e concerns raised by the European Union.  
He noted that the United States was not aware of an y scientific or technical evidence that would prove 
the risks to the environment from the use of thin-fi lmed solar panels.  He also mentioned the study 
highlighted by the European Union, noting that it co nfirmed suspicions in industry that there was in 
fact a de facto ban in place, which would continue to exist until the research and development 
exercise in the field was complete and Korean pr oducers were able to compete in those technologies; 
in other words: those products would only be a llowed onto the market when domestic presence of 
such products had been established. This was an i ssue of concern.  The representative of the United 
States also reiterated concerns about the issue on cadmium and noted that while several countries 
including the United States mainta ined rules for the safe use of cadmium, the small quantity of 
cadmium contained in the solar panels did not warrant being blocked from KEMCO16 certification.  
This only created unnecessary delays for market en try of innovative products which were already 
being sold in other countries.     
225. The representative of the Korea confirmed that  the Korean certification system was not 
mandatory, therefore non-silicon based, thin-film sola r panels did not face difficulties entering into 
the Korean market even without the KS certification.   He also mentioned that the feasibility study on 
the environmental impact assessment had started in  2010 and was still in progress; it was expected to 
be completed by 30 May 2012.  He noted that the Ministry would decide on the inclusion of solar 
panels KS 61646 upon completion of the study.  Members would be informed in due time. 
(xvii)  India - New Telecommunications related Rules ( Department of Telecommunications, No. 842-
725/2005-VAS/Vol.III (3 December 2009); No. 10-15/2009-AS-III/193 (18 March 2010); and Nos. 10-15/2009-AS.III/Vol.II/(Pt.)/(25-29) (28 July 2010); Department of Telecommunications, No. 10-15/2009-AS.III/ Vol.II/(Pt.)/(30) (28 July 2010) and 
accompanying template, "Security and Business Continuity Agreement") 
226. The representative of the European Union ac knowledged the issuing of an amendment on 31 
May 2011 by the Indian Government to the ru les governing licensing agreements with telecom 
                                                      
15 http://www.ul.com/ . 
16 Korea Management Energy Corporation. G/TBT/M/54 
Page 48  
 
  service providers.  He noted that the understanding  was that the amendment would supersede all 
previous rules with immediate effect; he requested the Indian delegation to confirm this understanding 
from a legal perspective and that it would solely  be this amendment that governed the licence 
agreement between the governments and te lecom service providers henceforth.   
227. He also noted that, in the previous month, th e European Union and European industry had had 
extensive discussions with Indian authorities - he wa s grateful that the amendment contained several 
positive elements to address significant substantive concerns raised by the European Union with 
previous rules.   For instance, he referred to th e fact that telecom service providers were made 
responsible for adopting all possible necessary measures to ensure the appropriate level of security for 
their networks and for creating an organisational policy on security and security management.  Since 
the telecom service provider was best placed to de termine the appropriate level of security and the 
measures that needed to be taken to achieve it this element was very positive.  He also noted that there 
was no longer a mandatory template agreement be tween telecom service providers and vendors of 
equipment, which was a positive development since,  given the specificities of the telecom network 
and the equipment operated on it, the content of the agreement was best left to negotiations between 
the telecom service provider and the equipment vendors.  Moreover, there was no longer a 
requirement for equipment vendors to deposit their s ource code in an escrow account.  That had, for 
the European Union, been a significant concern fro m the perspective of protection of intellectual 
property rights and legitimate commercial interests of equipment vendors.  With reference to the 
liability in case of security breaches, he noted th at the amendment removed the unlimited liability 
provision by providing a ceiling of roughly eight million Euros.  He also underscored that there was a 
reference to relevant international standards on information security.    
228. Some further adaptations were, however, necessar y.  For instance, on the validity period for 
acceptance of foreign test reports.  He noted that the new rules provided for the acceptance of foreign test reports and certificates issued by competent foreign laboratories and certification bodies such as 
those approved by the contracting parties to th e CCRA (Common Criteria Recognition Agreement).  
He highlighted, however, that the provision was onl y valid until 31 March 2013 and that, as of 1 April 
2013, it was expected that the obligation for in-count ry testing using Indian labs exclusively would 
come into force.  He requested a clarification on the rationale for the decision with regards to the 
flexibility afforded to equipment vendors to choo se the laboratory in which to have their tests 
conducted.  He requested the Indian authorities to  reconsider this decision and to allow for the 
possibility of using competent, internationally accr edited laboratories even after 1 April 2013.   
229. The representative of the European Union also raised for discussion the new amendment that 
foresaw that the equipment vendor would have to pr ovide the licensee details about the software used 
in the equipment and would have to allow the te lecom service provider and/or the Department of 
Telecommunications of the Indian Ministry of Communications and IT, to inspect the hardware, 
software, design, development, ma nufacturing and supply chain, and allow for security checks of the 
supplies of the equipment at any point.  He re quested confirmation that such checks would be 
minimised and restrained to manufacturing facilities only and be therefore conducted in a such a way 
so as to safeguard the legitimate commercial inter ests of vendors would be adequately protected.  
Finally, regarding penalties in case of security br eaches, the representative of the European Union 
welcomed the provision of the upper ceiling, noting howe ver that it might be useful for the purpose of 
legal certainty and more predictability if more deta iled guidelines would be developed as part of the 
implementation, so as to set clearer criteria a llowing full proportionality between the amount of the 
penalty applied and the gravity of the breach in question.    
230. The representative of Japan remained concerned about the security-related amendments to the 
Unified Access Service Licence Agreement.  He not ed that on 31 May 2011, India had announced the 
new rules - as part of this the requirement for fo reign vendors of telecom services to transfer their 
technology within three years and place their s ource codes in escrow had been deleted.  He  G/TBT/M/54 
 Page 49 
 
 
  acknowledged this development as the old rules viol ated the principle of national treatment and 
infringed on intellectual property rights.  However, he  also raised concerns with the new rules, noting 
that Japan was currently in the process of de termining the impact of these rules on Japanese 
companies.  He cited examples of specific provisi ons.  According to the said new rules, beginning 
April 2013, network elements w ould only be permitted if they had been approved by Indian 
certification agencies.  He underscored that the a pproach might not comply with the CCRA (Common 
Criteria Recognition Agreement) given that India had accepted the scheme of the CCRA.  He reiterated that India should ensure that its teleco m regulations did not reduce market access for foreign 
companies.   
231. The representative of the United States reitera ted concerns raised with India's telecom 
licensing amendments and shared the position taken by other Members on the subject.  He noted that 
India had issued new rules to replace previous amen dments that had raised issues for Members.  The 
United States welcomed the more open consulta tive processes, especially those with respect to 
industry stakeholders, that were considered for devel oping the new rules.  He urged India to notify the 
new proposal to the TBT Committee for comments.   
232. The representative of India said that the provision of 31 May 2011 categorically stated that it 
superseded all other provisions and was the final amendment on Article 41.6(a) of the Unified Access 
of the Licensing Agreement.  India did not think th at security guidelines were technical regulations 
within the purview of the TBT Agreement and did not see why the issue was being raised in the TBT 
Committee and why there was a need to notify th e measure to the Committee.  However, he 
mentioned that India had displayed the highest level of  transparency on a subject with implications for 
national security and had engaged w ith all stakeholders at the highest administrative level and taken 
out clear instructions on the security guidelines, even  in the absence of any specific obligations to do 
so, given their security implications.     
233. The representative of India informed the Committee that the Department of 
Telecommunications (DOT) and the Ministry of Home  Affairs had held high level meetings with the 
telecom service providers on 2 May 2011 to discuss their concerns on the security guidelines.  
Together the two ministries had developed the revised  regulation on 31 May 2011.   He also sought to 
alleviate concerns of Members such as those of  Japan and the European Union under paragraphs 
(vi)(a) and (viii) of the guidelines noting that the provision of software details would not entail the 
supply of source codes; moreover, origin had be en deleted from where it previously was in the 
guidelines.   
(xviii)  Brazil - Instructions for Registration for Labe ls of Imported Products of Animal Origin 
(G/TBT/N/BRA/385)  
234. The representative of the United States appr eciated Brazil's willingness to address concerns 
raised by amending the registration form but noted that there remained some issues on which further 
clarification was needed. 
235. The representative of the European Union continue d to be concerned about the requirement to 
register the labels of products of animal origin, a nd to have them approved be fore being marketed in 
Brazil.  The European Union was monitoring the situ ation to ensure that this requirement would not 
create unnecessary delays and costs for EU exporters. 
236. The representative of Brazil explained that the new measures were aimed at simplifying 
procedures for the registration of labels of products  of animal origin.  He recalled that Brazil had 
extended the consultation period for the measure in li ght of the concerns expressed by some Members 
and postponed its entry into force until 2011.  Fo llowing this extended consultation, the draft 
regulation had been reformulated to reflect th e comments received.  Among the points removed G/TBT/M/54 
Page 50  
 
  (G/TBT/N/BRA/385/Add.2) was the requirement that  an exporting Member authority should state on 
the registration form that the product in question was in compliance with several aspects of Brazilian 
regulations.  He explained that the date for entr y into force of the new measure had again been 
extended, until April 2011 for new products, and April 2012 for products already registered in Brazil.  
The delegation of Brazil was of the view that the re maining issues could be dealt with bilaterally and 
invited interested Parties to enga ge with Brazil in this regard.  
(xix) Indonesia – Labelling Regulations (Ministry of Trade Regulation 62/2009 and 22/2010)  
(G/TBT/N/IDN/47)  
237. The representative of the European Union stress ed that while her dele gation did not question 
the obligation to label goods in the Indonesian la nguage, she failed to see why labelling of a wide 
range of goods had to be  approved by the Indonesian authorities before import, and why labelling had 
to be done before goods entered the Indonesian customs areas.  She supported the objective of 
providing consumers with relevant in formation on goods that they were  able to read and understand, 
but argued that this could also be achieved by impor ters adding stickers with the relevant information 
in the appropriate language before the product was placed on the market rather than before entering 
Indonesian territory.   In case there were concerns about insufficient control of such re-labelling 
through market surveillance, she enquired as to wh ether a specific area for product re-labelling after 
entry into the customs area was a feasible proposition.  She argued that this would be less burdensome, and would still fulfil the consumer protection objective. 
238. The representative of the United States echoed th e general concern of the European Union.  
He requested that Indonesia permit supplementary la bels to be applied at importers' warehouses or 
other approved in-country locations after  a product had cleared customs, but prior to distribution.  To 
require labelling prior to shipment would prove cost ly and restrictive given the constraints of supply 
chains and consolidated shipments.  Furthermore, he proposed that Indonesia allow importers to self-
declare conformity with labelling requirements rather  than having the requirement of a Certificate of 
Approval following submission of an acceptable sample  label to the Indonesian Ministry of Trade. 
239. The representative of Australia was concerne d about conflicting advice about the labelling 
regulations.  The Indonesian Ministry of Trade officials had confirmed that Regulation 69/1999 
allowed labels to be applied to food products in Indonesia, wher eas the Indonesian National Agency 
of Drug and Food Control stated that Regulati on 62/2009 and 22/2010 prohibited the use of labelling 
stickers.  This had led to some confusion as to whether the regula tions applied to both food and non-
food products.  Australia sought to co-operate  with Indonesia and supported its policy objectives 
without creating an onerous burde n on exporters or disrupting trad e.  Australia preferred that 
exporters would be allowed to u se labelling stickers, which they considered to be the least trade-
restrictive option.  Indonesia was encouraged to en sure that its labelling st andards were consistent 
with existing international standards such as those of Codex, which offered guidance on the use of in-
country secondary labels in-country. 
240. The representative of Indonesia said that Memb ers' comments would be considered as input 
into future reviews of the above-mentioned regulati ons.  She clarified that rules concerning labelling 
of products before  entering the customs area (Article 2 paragraph 3 of the Regulation of the Minister 
of Trade No. 22/M-DAG/PER/5/2010) stated that labe ls in the Indonesian language were applied to 
all goods which entered into the cu stoms area of the Republic of I ndonesia.   Both domestic producers 
and importers were require d to submit a sample label to the Ministry of Trade Directorate of Supply 
Goods and Service Control in order to obtain certific ation of labelling in the Indonesia language - this 
was, in fact, a means of pre-market surveillance us ed to assist in the control of goods, particularly 
imported goods, in accordance with the respective regula tions applied.  She noted that clauses of the 
Regulation of the Minister of Trade No. 62/2009 and 22/2010 stated that the obligation of affixing labels in the Indonesian language was an important pr erequisite that had to be fulfilled by importers  G/TBT/M/54 
 Page 51 
 
 
  bringing goods into Indonesia. The representative of  Indonesia also described the Indonesian National 
Single Window (INSW) system which enforced co mpliance with restrictions and prohibitions on 
imports.  Importers were required to submit documents concerni ng their products, together with a 
certificate of affixing labels in Bahasa Indonesian, or  a duty exemption letter of affixing labels in the 
Indonesian language. 
241. The Indonesian Government view was that Impl ementation of the Regulation of the Minister 
of Trade No. 62/M-DAG/PER/12/2009 concerning Obligatory Label Affixi ng on Any Goods and 
Regulation of the Minister of Trade RI No. 22/ M-DAG/PER/5/2010 was aimed at giving consumers 
the right to correct and clear information, as stated in Act No. 8/1999 on consumer protection.  The procedure was not intended to create barriers to trade.   Regarding the content of the label, she stated 
that type or brand of the good in question was the most common inclusion - but the inclusion of both 
type and brand was optional; the producer and importe r were at liberty to include both the type and 
brand.  For instance, for a leather logo, the inclus ion of this logo for goods made from genuine leather 
was at the discretion of the importer/producer; inclus ion would have to be c onducted in a responsible 
manner. With respect to a care label, information on use and care was voluntary (if necessary) - in this 
context information was to be determined by the producer, given their knowledge of the 
characteristics of the products.  The "Made in" labe l could include general information on where the 
product was made. For footwear (printed or sticke red), the Regulation of Minister of Trade No. 
62/2009 and 22/2010, notably in Article 6, stated that  "The label referred to in Article 2, paragraph 
(1), shall contain information or explanation of the goods and the identity of the producer or importer as set forth in attachment to this Regulation".  The attachment to Regulation of Minister of Trade No. 
22/2010 contained information on what would need to  be printed on the label, and what information 
could be added by sticker. 
242. The representative of Indonesia went on to note that the provisions for exemption of 
producers and importers from the ob ligation of labelling in the Indonesi an language were available in 
Article 11 of the Regulation of Minister of Trade RI No. 22/M-DAG/PER/5/2010. This article, 
particularly paragraph (1), stated that “The obliga tion of affixing labels in Indonesian language as set 
forth in this regulation does not apply to goods which are sold in bulk and packaged directly in front 
of the consumers" - separate procedures we re provided for obtaining the exemptions.  
243. With respect to food products, the representa tive of Indonesia explained that her government 
had been implementing the provisions on labelling in Indonesian language for food products through 
Act No. 7 Year 1996 for food. The respective provisions were most clearly stated in Article 31 
paragraphs (1) and (2) which indicated that: (i) "a ny person producing or importing into the territory 
of Indonesia, food which is packed for sale is oblig ated to place a label on, within and or on the 
packing of the food" and (ii) "The label as referred to in paragraph (1) shall at least contain information concerning: the name of the product; the list of materials used; net weight or net contents; 
name and address of the party which produces or imports the food into the territory of Indonesia; 
information on "halal" (legally permitted) and; the e xpiry date, month and year.  It was noted that the 
Government Regulation No 69 Year 1996 concerning F ood Labelling and Advertising, particularly in 
Article 15 stated that "Information on the label, wr itten or printed in Indonesian language, in Arabic 
Numbers and Latin letters".
 
(xx) European Union - Proposal for a Council Regulation on the Indication of the Country of 
Origin of Certain Products Imported from Third Countries (SEC(2005)1657)  
244. The representative of the United States requ ested an update from the European Union on 
developments in the European Parliament and on the process by which the European Commission 
would solicit input from Members and other stakeholders.  G/TBT/M/54 
Page 52  
 
  245. The representative of the European Union expl ained that the European Parliament had 
introduced a number of significant amendments to the Commission's proposal at its first reading, 
notably limiting the scope of application of the draf t regulation to a list of end consumer goods as well 
as a review clause.  The Council of Ministers was currently examining the Parliament's amendments, 
but without a set date for the adoption of a Common Position.  It was probable that text resulting from 
the first reading of both institutions would signi ficantly modify the original Commission proposal and 
any detailed discussion would therefore be prematur e.  She explained that the Commission would 
examine whether the draft text contained any TBT elements at the time of the adoption of the 
Common Position by the Council, and in such a case would look into the need to notify the measure 
to the TBT Committee.  
(xxi) Turkey – Communiqué SUT 2010 regarding documenta tion requirements for medical devices  
246. The representative of the United States expressed c ontinuing concerns about Turkey's medical 
device reimbursement regulation, communiqué  SUT 2010, specifically the requirement for producers 
of medical devices used in certain types of sp inal, traumatology and orthopaedic arthroplasty 
procedures to comply with a second regulation, in addition to the Ministry of Health regulation 
affecting producers of medical devices.   It was noted that no opportunity for comment had been given 
as the regulation had not been notified to th e WTO and the United States was still awaiting 
clarification from the Turkish Government of the purposes for the second regulation, which was 
effective almost immediately after its publication.  In particular, the United States had asked about the 
reasoning behind the product selection, if potential broadening of the scope of the second regulation 
would be likely and if so, whether the addition of products would be notified for comment.  The 
representative of the United States urged Turkey to  examine the transparency provisions in the TBT 
Agreements and to notify the measure, as well as  any amendments, to the WTO for comment.  He 
suggested that Turkey discuss the concerns of stak eholders with the industry and eliminate or modify 
any unnecessary documentation requirements to enable  suppliers to continue to place their products 
on the Turkish market. 
247. The representative of Turkey referred to explana tions at previous meetings of the Committee 
and noted that any medical device, imported or do mestically produced, would be able to enter the 
Turkish market if it carried the CE mark.  She explained that the aforementioned Communiqué  
enforced by the Turkish Social Security Institu te set out the conditions and requirements for 
reimbursement of medical device payments, along w ith other products within the social security 
system.  She added that these conditions and require ments only applied to products the payments of 
which were made by the Social Security Institution for the beneficiaries of the system.  The Turkish 
Social Security Institution covere d the health expenditures of a la rge proportion of the population, and 
aimed to serve the public interest while protecting public health by ensuring that the most efficient 
medical devices were provided to patients, but also  aiming to keep expenditure within a pre-assessed 
budgetary target. 
248. She noted that the specific product groups to  which the documentation requirements applied 
were those used more frequently in medical opera tions.  These were the products for which patient 
complaints regarding quality deficiencies were raised  most often.  She stressed that the documentation 
requirements of the Institution were neither exce ssive nor applied in a discriminatory manner for 
imports.  They were essentially required by the originating country authorities for market authorizations.  She said the Institution theref ore did not effectively create any documentation 
requirements or conformity assessment procedure, a nd furthermore, the Social Security Institution had 
not received, to date, any complaint from the industry regarding difficulties in fulfilling the documentation requirements.  She invited US indus try to provide more information on any specific 
problems encountered in the implementation of the Communiqué.  Finally, she noted that a draft of the measure had been published on the official Ins titution website two months prior to enforcement  G/TBT/M/54 
 Page 53 
 
 
  with interested parties given the opportunity to comment for a period of two months.  Nonetheless, 
notification to the TBT Committee of the communiqué was under consideration. 
(xxii)  Italy - Law on "Provisions concerning the marke ting of textile, leath er and footwear products 
(G/TBT/N/ITA/16)  
249. The representative of India said that the pr oposed law required compliance with a large 
number of regulations and the provision  of information at each stage of processing.  He argued that an 
industry premised upon global and multiple sourcing w ould find it difficult to meet these criteria; 
particularly the exporters from developing countri es.  Indeed, the requirements proposed by Italy 
could be more restrictive than necessary and inconsis tent with the requirements of Article 2.2 of the 
TBT Agreement.  Furthermore, the requirement s imposed under the Marketing Law modified the 
condition of competition for imported products from de veloping country Members and could result in 
less favourable treatment for imported products as co mparable to products from Italy - this was 
inconsistent with the requirements of Article 2.1 of the TBT Agreement and Article III.4 of the 
GATT.   In addition, the requirement to provi de details of employmen t was a non-product related 
process and production methods (PPM) that was not cove red within the scope of the TBT Agreement.  
He explained that India believed that this info rmation requirement was clearly unwarranted as it 
sought to interlink labour issues with trade.  Such non-product related PPMs also altered the 
conditions of competition to the detriment of importe d goods and therefore violated the provisions of 
GATT 1994.   
250. The representative of India also raised concer ns about the reference to compliance with 
regulations on the environment and he questioned the inter-linkage between trade and environmental 
issues, arguing that this would constitute a trade ba rrier affecting exports from developing countries.  
He sought clarification as to whether Italy had given due consideration to less trade-restrictive 
regulatory alternatives in pursuit of its objectives an d asked whether the concerns of Indian industry 
over the proposed regulation had been taken into consideration. 
251. The representative of Argentina requested clarif ication from Italy and the European Union as 
to whether other European countries applied laws or dispositions or impl emented standards with 
similar characteristics.  He as ked for information on which Inte rnational Labour Organization (ILO) 
and environmental agreements had b een referred to by this law and what mechanisms were in place to 
certify an environmental or labour standard - and how and by whom the certification would be done. 
252. The representative of the European Union refe rred to previous Committee meetings where 
these concerns had been noted.  As explained then , the application of the Italian law concerning the 
marketing of textile leather and f ootwear had been postponed until the adoption of an Inter-Ministerial 
Decree pursuant to Article 2 of the Law.  This decree  had not been adopted and was not foreseen to be 
adopted in the near future.  It was therefore cu rrently not necessary to discuss the detailed questions 
put forward by Argentina and India. 
(xxiii)  Brazil - Draft Resolution No. 112, 29 November 2010; maximum levels of tar, nicotine and 
carbon monoxide permitted on tobacco products and prohibition of additives 
(G/TBT/N/BRA/407) 
253. The representative of the European Union suppor ted the objective of protecting human health, 
which Brazil had indicated as the rationale behind its draft resolution, but referred to previous 
comments.  Specifically, the proposed measure would imply that EU exports of traditionally-blended 
tobacco products to Brazil and its exports of additives currently used in tobacco would be 
discontinued. She highlighted that the European Un ion was itself in the process of revising Directive 
2001/37/EC on the approximation of laws, regulations and administra tive provisions of the Member 
States concerning the manufacture, presentation and sal e of tobacco products and had identified the G/TBT/M/54 
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  regulation of ingredients as one policy area that c ould potentially change.  She recalled that a number 
of questions had been raised by the European Union at the previous meeting and, while acknowledging Brazil's helpful responses to several , noted that others remained unanswered. 
Specifically, she invited Brazil to clarify the gro unds justifying a ban on additives over setting limits 
on use.  At the previous meeting, Brazil had indica ted that previous attempts to regulate aromas and 
flavours had been unsuccessful, but had offered no clarif ications as to how this justified a complete 
ban. Furthermore, the European Un ion was also interested in whet her Brazil had conducted an impact 
assessment, including on the consumption of tobacco products, as well as on growers and 
employment - particularly if Brazil had consider ed possible consumption shifts to additive-free 
cigarettes, such as Virginia tobacco .  She requested a copy of any impact assessment, or a summary of 
its conclusions, if one had been carried out. A dditionally, at the previous meeting Brazil had 
mentioned that its authorities had information indicati ng that additives enhanced the effect of nicotine, 
thereby making cigarettes more addictive.  She requested more information on those studies, including the references of these studies to enable  their evaluation by EU experts. Finally, the 
representative of the European Unio n requested an update of the st ate-of-play and asked Brazil to 
provide a written reply to its comments on the TBT notification before the adoption of the notified 
draft. 
254. The representative of Mexico endorsed the Eu ropean Union's concerns and asked for 
assurance that comments had been taken into acc ount, if a written response to submitted comments 
would be forthcoming, and details about when  Brazil planned to implement the regulation. 
255. The representative of Chile requested time to  prepare supporting evidence, citing the WHO 
document on tobacco control which supported governme nts giving consideration to scientific and any 
other kind of technical evidence.  He supported the aim of reducing consumption to protect the health 
of young people but argued that these objectives could be achieved through less-restrictive barriers to 
trade. 
256. The representative of Honduras was of the view that the Resolution would prohibit practically 
all types of additives, including menthol, representing a de facto  ban on the marketing and sales of 
products containing certain types of tobacco, such as Burley and Oriental tobacco.  Honduras remained concerned as Burley tobacco represente d a significant proportion of its production and the 
draft Resolution would ban its use in Brazil, d ecreasing Honduran exports and national production.  
He argued that even though additives did not n ecessarily produce a specific flavour, the majority 
would be banned without supporting scientific or t echnical evidence; he added that no scientific 
evidence suggested that specific flavours would create a consumption pattern or make smoking more 
attractive.  Honduras was concerned about the nega tive impact on its economy in the long-term. 
257. The representative of Turkey questioned the defi nition of additives listed for prohibition in all 
tobacco-related products, specifically the inclusion of any substance or compound other than tobacco 
or water used to process, manufacture or pack tobacco-based products, including flavourings.  The 
extensive list of prohibited additives and lack of supporting scientific evidence of any increased risk 
to human health concerned Turkey as the draft reso lution would prohibit Burley and Oriental tobacco 
used in traditional blended products.  Turkey ha d submitted comments and ur ged Brazil to consider 
them and amend the draft resolution to comply with its TBT obligations. 
258. The representative of Colombia asked how Brazil would make use of the comments and 
queries received, suggesting they would prove a usef ul basis for a resolution more in-line with the 
TBT Agreement.  He asked Brazil to provide upda tes on progress and reiterated concern that the draft 
would be set out and implemented as notified under G/TBT/N/BRA/407.  He al so asked for access to 
the scientific evidence used  to justify the prohibition of the additives in question and any studies 
demonstrating the ineffectiveness of less-restrictive measures.   G/TBT/M/54 
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  259. The representative of the Philippines was of the view that the draft resolution was arbitrary 
and unjustified discrimination, which would potent ially result in a total ban of traditional blended 
cigarettes. 
260.  The representative of Brazil informed the Committee that the draft regulation and the 
comments received were still under consideration, th at responses would be forthcoming and that he 
was unable to indicate when the final regulation woul d be published.  He stressed that the objective 
was the legitimate protection of public health, with pa rticular attention given to Article 1.2.1.1 of the 
partial guidelines to the implementation of Articl es 9 and 10 of the WHO's Framework Convention on 
Tobacco Control. He recalled that the name "partial guidelines" only indicated that some parts of the 
instrument were pending further discussion while othe rs were already fully approved. Article 1.2.1.1 
was one of the provisions that had been unanimous ly approved by WHO and stated that, from a public 
health perspective, there is no justification for pe rmitting ingredients such as flavouring agents, which 
made tobacco products more attractive.  He ob served that Articles 3.1.2.1 and 3.1.2.2 of these 
guidelines were similarly unanimously  approved, and stated that regulation of ingredients aimed at 
reducing product attractiveness could contribute to  reducing the prevalence of tobacco use and 
dependence among new and continuing users.  Those ar ticles also stated that  attractiveness and its 
impact upon dependence should be considered when  designing regulatory measures; and that the 
harsh and irritating character of tobacco smoke provides a significant barrier to experimentation and initial use. He referred to tobacco industry docu ments describing significant efforts to mitigate those 
negative characteristics of tobacco smoke.  He cited a survey conducted by the Brazilian National 
Institute on Cancer (INCA) that had found that 45 per cent of people aged 13-15 consumed flavoured 
tobacco products. 
261. For Brazil the measure was necessary given the failure of previous efforts to prohibit 
flavoured products rather than additives, due to the subjectivity of assessing flavouring and smells of 
products.  Furthermore, according to informatio n received by the Brazilian Government, the 
processing of Burley tobacco without additives was technologically feasible since 1996. He explained 
that evidence existed that some additives (i ncluding acetaldehyde, levulinic acid, gamma-
valerolactone and ammonia) strengthened the effect of nicotine. In addition, some studies indicated 
that, besides increasing the addictiveness of tob acco products, some additives, when burnt, could 
augment the carcinogenic properties of cigarettes. He informed Members that Brazil had compiled 
scientific references related to the properties and ef fects of additives and offered to share them with 
interested Parties.  Finally, he referred to Braz il's production of Burley tobacco, highlighting that the 
measure did not differentiate between domes tic and foreign producers and was thus non-
discriminatory.  
(xxiv)  China – Requirements for information security pr oducts (including, inter alia, the Office of 
State Commercial Cryptography Administration (OSCCA) 1999 Regulation on commercial encryption products and its on-going revision an d the Multi-Level Protection Scheme (MLPS) 
262. The representative of the European Union referre d to previous statements on the issue and 
requested an update on the timeline of the revision process of the Regulation on commercial 
encryption products managed by OSCCA, which at th e previous meeting China had confirmed to be 
part of the 2011 State Council legislative agenda.  In  particular he enquired as to how transparency 
would be ensured, and specifically how consulta tion of interested parties would take place in 
accordance with China's domestic regulations and wh en a TBT notification would be made. In this 
regard, he highlighted the need for that consultation and the TBT notification to take place at an early 
appropriate stage, in order to provide stakeholders with a meaningful opportunity to provide input.  
On the implementation of the MLPS, he noted that China had previously clarified that the MLPS was 
a regulation that classified information security syst ems according to the level of their sensitivity for 
national security, and had confirmed that not onl y governmental bodies but also the financial and 
banking sectors as well as public utilities were impacted by the classification as critical infrastructure.  G/TBT/M/54 
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  In the European Union's view, this confirmed the potential of the MLPS to impact upon areas not 
generally considered to be sensitive for national secu rity in other jurisdictions, including commercial 
sectors such as banks and financial institutions.  He  explained that, in the European Union, for 
instance, banks and financial institutions were responsible for ensuring the security of their 
transactions and taking all appropriate measures to th at effect. He called for greater transparency in 
the implementation of the MLPS, including the notification of relevant implementing rules. Finally, 
he thanked China for keeping a channel of communi cation open, and reiterated the European Union's 
commitment to reinforcing bilateral cooperation a nd having fruitful discussions with the Chinese 
authorities on these issues with all relevant actors on the Chinese side. 
263. The representative of the United States sai d that his delegation was monitoring the 
development of this regulation given the potential impact of changes to information security 
requirements in China if the scope of covered pro ducts was to expand.  He requested an update on 
proposed changes to the Office of State Comme rcial Cryptography Administration (OSCCA) 
regulations, including any indication of an eventual notification of the measure to the WTO TBT Committee.  With respect to the MLPS, he explaine d that the United States had two concerns if the 
currently drafts were fully enforced or  the product scope was to be expanded. 
264. First, all information technology security products used in IT systems classified at level 3 or 
above under the MLPS would need to contain indi genous intellectual property.  In addition to 
discriminating against foreign products, he argued that the measure would lower national security: 
security of products was not related to nationality of producer or origin of intellectual property, but to 
the quality of the specific system, the use of inte rnational standards and other objective criteria.  
Limiting the use of foreign products would also reduce the number of available information security 
technologies, ensuring that many of the most innov ative security solutions would be excluded from 
China.   Second, any products listed in the certif ication directory of information security products 
would need to acquire a certificate issued by a national information security product authentication 
organization.  Having to provi de confidential business inform ation to a government-affiliated 
laboratory where there was no protection of confidentiality would be a disincentive for foreign 
companies to supply IT products to the Chinese market for fear that intellectual property and product security could be put at risk.  He urged China to ad opt and participate in development of international 
standards for product assurance in the informati on security area, including the common criteria. 
265. The representative of Japan supported other con cerned delegations and said that the Chinese 
schemes and regulations on information security woul d pose problems for future trade in information 
security products.  He argued th at these schemes were not in line with global standards and practices, 
and that Japan was paying particular attention to how these measures could negatively affect trade in 
information security products; the most recent i ssues being the OSCCA regulations on encryption and 
the MLPS.  He recalled that other delegations ha d expressed desire for China to be prudent in 
introducing additional measures regard ing information security and looked forward to being informed 
of how China intended to proceed. 
266. The representative of China informed the Committ ee that bilateral discussions were held with 
the European Union, the United States and Japan.  He informed the Comm ittee that the Commercial 
Cryptography Administrative Regulation by OSCCA was still on the agenda of the Legislation Plan 
of the State Council (2011).  As its draft was not re ady, he did not think it was proper to discuss it in 
the TBT arena now.  As for the Regulation on Classified Protection of Information Security, he 
argued that systems covered by Level III and above only took a sma ll percentage of IT systems 
among major industries.  As for the concerns of th e US delegation, he invited the US to provide 
concrete examples.  As for the global norm menti oned by the Japanese delegation, he invited the 
Japanese delegation to explain what was global no rm in the field of information security.  G/TBT/M/54 
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  (xxv) Indonesia - Draft Decree of Minister of Industry on Mandatory Implementation of Indonesia 
National Standard for electrolysis tin coat ed thin steel sheets (G/TBT/N/IDN/46) 
267. The representative of Korea reiterated concer ns that new technical guidance had not been 
released and Korean steel manufacturers were ther efore unable to adequately prepare and apply for 
SNI certification for tin-plated electrolyzed thin steel bars.  He asked for information on the 
establishment process of the draft Decree and de tailed technical guidance as soon as it became 
available. 
268. The representative of the European Union referre d to past comments on mandatory third party 
certification for certain steel products.  She noted th at Indonesia had previously stated that it could 
accept certification from other countries and sought de tails of the criteria for such an acceptance - 
specifically whether EU Suppliers' Declarations of Conformity (SDoC) would be accepted.  Finally, 
she requested a response to the concerns and requests for clarification that had been submitted to the 
Indonesian Enquiry Point in writing on 23 March 2011. 
269. The representative of Japan supported the pr eceding interventions, expressing concern over 
possible further expansion of the mandatory standards.  He noted that Japanese steel mills already 
implemented strict quality management systems certified by ISO9001 and this expansion would 
increase the time and cost required to obtain and ma intain certifications, likely impacting negatively 
on foreign trade by increasing distribution costs and delaying supply to major Indonesian industries and therefore causing Indonesian industries to  be less competitive in the global market. 
270. The representative of Indonesia informed the Committee that the draft Decree was still being 
finalized, and would enter into force six months af ter the day of publication.  During the six month 
period, technical guidance would be prepared by the Indonesian Ministry of Industry and adopted 
prior to the date of entry into force.  She added that SNI would not be implemented before entry into 
force, thus importation procedure would refer to the previous regulation until that date.  She explained 
that certain steel products, which had different technical specifications but fell under the same HS 
numbers were not covered by the mandatory implem entation of SNI.  Elaborating, she said that 
imports of these products should be accompanied by a le tter of technical consideration issued by the 
Indonesian Ministry of Industry, and no rule or re gulation on quotas that applied to these products was 
currently in place. 
271. The representative of Indonesia said that her government would design the regulation based 
on the following considerations: consumer protectio n, improvement of product quality, and fostering 
fair trade competition.  With regard to the latter,  Indonesia intended to use the regulation to ensure 
that electrolysis tin-plated thin steel sheets complied  with the requirements in SNI, thereby ensuring 
consumer safety.  She explained that SNIs fo r steel products which would be implemented as 
mandatory requirements referred to standards of some WTO Members; SNI had been developed by 
consensus through stakeholder engagement, taking in to consideration the development of technology 
and the capacity of manufacturers.  Product certifica tion bodies designated by the Indonesian Ministry 
of Industry could outsource product testing to the respective laboratories outside Indonesia; 
laboratories could only be appointed if the country  in question had signed a bilateral or multilateral 
agreement with the Government of Indonesia.  She said that an agreement could be made by 
considering a Mutual Recognition Agreement (M RA) between KAN and the accreditation body of 
another country.  She would keep Members up to date on the timeline for implementation once the 
regulation and technical guidance had been finalized. 
(xxvi)  Colombia - Alcoholic Beverages (G/TBT/N/COL/121 and Adds.1-3) 
272. The representative of the United States appreci ated the cooperation from Colombia thus far 
and said that some additional issues had been rais ed for discussion.  These included the recognition of G/TBT/M/54 
Page 58  
 
  distinctive products, formulating pos itive lists of food additives, as well as certain parameters on 
alcohol content. 
273. The representative of the European Union expl ained that the European Union continued to 
have several concerns which would be submitted in  writing.  In particular she referred to the 
definitions of alcoholic beverages, which conti nued to cause a number of concerns - including the 
upper alcohol limit for fruit spirits, the definition of  liqueurs, brandy and vodka, and the requirement 
of oak containers for rum production.  She asked for clarification of the sanitary interest of requiring labels to be affixed at origin, emphasizing that this could prove problematic, particularly for low-
volume imports.  She also asked whether the requireme nt of presentation of a quality certificate at the 
time of importation was also applicable to locally-produced goods.  Finally, she enquired as to how 
goods legally-imported into Colombia  before the legislation came into force would be treated, and 
whether they would be subject to the new requirements. 
274. The representative of Colombia reiterated prev ious comments made informing Members that 
the draft decree had been published on 5 Novemb er 2010, amending G/TBT/N/COL/121/Add.2.  This 
document set a deadline for comments of 4 February  2011.  This deadline was subsequently extended 
for a further three months at the request of Members and notified in G/TBT/N/COL/121/Add.3.  He 
noted that Colombia had dealt with concerns raised  by Argentina, Guatemala, Chile and the European 
Union, integrating several of their recommendations and comments.   
(xxvii)  China - Administration on the Control of Pollution Caused by Electrical and Electronic 
Products (G/TBT/N/CHN/140 and Add.1; G/TBT/N/CHN/140/Rev.1) 
275. The representative of the European Union sought an update on the status of the catalogue of 
products required to comply with pollution control,  recalling that in the previous Committee meeting 
China had explained that such catalogue was still under development, and would be notified to the 
WTO in due course.  She also recalled China's stat ement that mandatory, voluntary or other kinds of 
certification could be chosen for the purpose of certification. The European Union understood from 
that statement that Article 21 of the notified draf t did not automatically impose mandatory third party 
certification and the means of compliance assessment were still to be decided.  The representative of 
the European Union sought confirmation that this  understanding was correct, and asked China to 
elaborate on how the catalogue and certification procedures were linked. Finally, she expressed 
doubts over the necessity of a third party certification for controlling a risk that only manifested once products became waste, and not when the product was being used by the consumer. 
276. The representative of Korea noted an informa tion exchange on the issue in a bilateral 
meeting.  He voiced the concerns of the Korean industry on this regulation and explained that the 
State Recommendation Voluntary Certification System (SRVC) was viewed as de facto  mandatory 
certification because of government procurement an d tax benefits.  Only Chinese certification bodies 
designated by the Chinese Ministry of Industry a nd Information Technology (MIIT) and Certification 
and Accreditation Administration (CNCA) would provide acceptable tests, and he urged acceptance 
of results from third countries which would also test  according to international standards.  He asked 
for more detailed information on test methods  and the requirements of certification bodies. 
277. The representative of Japan sought clarification in  response to its comments.  He asked which 
type of certification system could be applied, as Japan was unsure if the "national certification system 
for the control of pollution caused by electronic products" could be a mandatory third-party conformity assessment, or a Voluntary Supplier's D eclaration of Conformity Certification (SDoC), 
which Japan advocated. He referred to Article 3( 1), concerning electrical and electronic products.  
The Chinese Government had explained that an ex empted products list was under consideration and 
he emphasized that automobiles, batteries, any pa rts and materials incorporated in "equipment and 
attached products", and any jig, tool and material used in the production of "equipment and attached  G/TBT/M/54 
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  products", were to be exempted from the definitio n of electrical and electronic products.  He also 
asked for an update on the status of the exempted products list for Article 3(1). 
278. The representative of the United States raised con cerns with respect to the administration and 
control of pollution caused by electrical and electr onic products, specifically the implementation rules 
for voluntary certification issued earlier in 2011.  He urged China to notify those procedures and 
postpone implementation until comments had been re ceived and taken into account.  He also asked 
China to indicate the objective and rationale of these certification procedures and requested clarification as to whether any incentives were lin ked to compliance with certification procedures. 
The United States understood that producers coul d receive incentives for compliance, including 
acceptance of certification results for CCC certifi cation purposes, tax relief for companies whose 
products were certified, and govern ment procurement opportunities; such linkages could make even a 
voluntary scheme de facto  mandatory.  The US representative sought confirmation of notification if 
and when voluntary measures would be made mandatory.  
279. The representative of China appr eciated the opportunity to clarify some points bilaterally with 
the EU, Canada, Japan, South Korea, and the United States.  He stated that China has replied in 
writing to comments from the US, Japan, and the EU, a nd for the EU,  there had been a second reply.  
He recalled previous statements at the last mee ting that the draft "Catalogue for Standard-reaching 
Management" contained a list of product categories,  and mandatory, voluntary, or other kinds of 
certification could be employed for conformity assessment.  He said that China would fulfill its notification obligation under the TBT Agreement. 
(xxviii)  India – Food Safety and Standards Regul ation - Food labelling requirements 
(G/SPS/N/IND/69) 
280. The representative of the European Union asked  whether the current practice of allowing 
labelling in customs warehouses would be maintained , as opposed to in the country of origin.  In 
addition, she sought clarification about the scope of the regulation with respect to alcoholic beverages, 
inter alia , if labelling requirements applied to all types of  alcoholic beverages or  only to "toddy"; only 
the latter was explicitly mentioned in point 5.9.5 of  the regulation.  If labelling requirements were to 
be extended to all alcoholic beverages, the Eu ropean Union would seek an exemption for the 
indication of food additives, date of manufacture a nd vegetarian/non-vegetarian declaration, and the 
acceptance of “single ingredient status” for the list of ingredients (e.g. “c ontains scotch whiskey” 
would avoid listing all ingredients).  She said that  India was deviating from Codex Alimentarius in 
certain areas, such as the obligati on to label certain aspects in capit al letters, which went beyond what 
would be necessary to safeguard a legitimate objective. 
281. The representative of the United States was concerned about the lack of a notification.  He 
appreciated the delay in enforcement of the re vised labelling provisions and India’s response to 
questions concerning the applicability of certain sec tions of the requirements to the distillation of 
spirits.  He expressed concern over India’s appli cation of date of produc tion labelling to distilled 
spirits and suggested that lot identification numbers  would prove more effective in the event of a 
product recall.  He urged India to remove this re quirement and also to reconsider the listing of 
ingredients for alcohol, given international practice of not requiring an ingredient list for non-nutritive 
products.  He asked India to follow international pr actice with respect to requiring labelling of flavour 
declarations on the part of the label covering the back  of the package, not the label on the front of the 
package as currently required. 
282. The representative of India stated that th e measure had only been notified to the SPS 
Committee as it related to consumer  safety and protection; it was intended to protect human health, 
which, he argued, was clearly covered by Annex A1(b) of the SPS Agreement.  He was unable to G/TBT/M/54 
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  offer specific replies to the concerns raised but pl edged to refer them to the Indian Food Safety 
Authority, who would respond in due course. 
(xxix)  Korea - PCV flooring material and Wallpap er and paper linoleum (G/TBT/N/KOR/303 and 
Add.1 and G/TBT/N/KOR/304 and Add.1) 
283. The representative of the United States reiterated concerns about the proposed content limits 
of 0.1 per cent for the three phthalates DEHP (Di- Ethyl Hexyl Phthalate), DBP (Di-butyl Phthalate) 
and BBP (Butyl benzyl Phthalate) in certain uses,  particularly for PVC flooring and wallpaper.  He 
sought more information from Korea on the propo sed content restrictions which he argued would 
effectively prohibit the use of these substances in tw o applications (flooring and wallpaper).  He noted 
that effect of under-floor heating had been offered as justification, but the United States was unaware 
of evidence that this would cause th e release of such substances in PV C flooring material. In addition, 
no explanation was given with respect to wallpaper .  Korea had since explained that a study on the 
release of hazardous substances in construction ma terials was the basis of their proposal, and he 
restated his request for a copy of the study. 
284. He added that US regulators had expressed gene ral concern regarding DEHP because of their 
toxicity, the United States Environmental Protec tion Agency (EPA) had published a plan outlining a 
number of actions to better assess exposure and poten tial safety concerns with DEHP, and the US and 
other countries had imposed restrictions on children’s toys and childcare articles, though as far as he was aware, this would be the first instance of r estrictions on DEHP in flooring and wall coverings. 
285. The representative of Japan supported the positio n of the United States, restating serious 
concern over the restriction of specific plasticisers such as DEHP, DBP and BBP in PVC flooring 
material and wallpaper.  In respon se to Korea’s citation of similar restrictions in other countries, he 
noted that Japan limited the content of DEHP in in fants’ toys to a maximum of 0.1 per cent, based 
upon the possibility of these toys being held in ch ildren's mouths for extended periods.  He argued 
that no other economy imposed similar regulations  on housing materials and found the regulation to 
be excessive. 
286. The representative of Korea noted that bilatera l discussions had taken place with the Japanese 
delegation that had provided specific information on long-term monitoring of phthalates indoors.  He 
reiterated that Korean houses employed Ondol, a unique, centuries-old under-floor heating system 
which meant most of these houses used PVC floorin g materials and wallpaper.  The Korean Agency 
for Technology and Standards (K ATS) conducted safety assessments for PVC wallpaper and flooring 
materials; they tested the phthalate-content of 46 PVC flooring materials and found it to range from 
16.4 to 20.8 per cent.  The second type test, rubb ing flooring materials with fabric, resulted in 
detection of a transferral of 0.13-0.71 ㎍/cm2 phthalates.  These results were positively correlated with 
higher floor temperature and formed the basis for the safety regulation.  KATS had gathered input on 
the proposed measure from industry and experts and had received very positive feedback.  Industry 
had not only agreed with the phthalate limit but regarded the measure as a positive regulation, which 
could encourage the development of alternatives a nd enhance competitiveness.  He added that Korea 
had informed the EPA of plans to regulate the leve l of phthalates in wallpaper and flooring and asked 
the United States to share the results of any work on phthalate regulation. 
(xxx) China - Provisions for the Administrati on of Cosmetics Application Acceptance 
(G/TBT/N/CHN/730) 
287. The representative of the European Union noted China's efforts to implement an efficient and 
comprehensive regulatory system for the approval of  cosmetics and efforts to clarify and streamline 
new requirements.  She also welcomed recent pr ogress by the SFDA in dealing with a backlog of 
applications for products without new ingredients.  She said that some issues  remained, most notably  G/TBT/M/54 
 Page 61 
 
 
  those tied to the registration of products contai ning new ingredients which had been impeded until 
recently by a lack of guidelines on the definition of a "new ingredient".  On 8 June 2011, China had notified a set of such guidelines to the TBT Comm ittee (as notification G/TBT/N/CHN/821), which 
had been already adopted on 12 May 2011 and would be implemented on 1 July 2011. The European 
Union was in the process of analysing these guidelines and would revert with more detailed questions 
in writing or bilaterally, but expressed hope that th ey would eliminate the existing difficulties in the 
registration of products with new ingredients.   
288. The representative of the European Union also informed Members that this issue was under 
discussion bilaterally under the framework of th e Working Group on cosmetics set up by the State 
Food and Drug Administration of China (SFDA) an d the European Commission's Directorate General 
for Health and Consumers (DG SANCO), whose next meeting on 21 June 2011 would allow these 
issues to be tackled at expert level.  She hoped discussions would prove fruitful, and thanked the 
SFDA for its openness and constructive approach.  She urged the SFDA to follow good regulatory 
practice when developing mandatory requirements – pa rticularly in allowing for sufficient stakeholder 
consultation and thorough impact assessment, notif ication to the TBT Committee at an early draft 
stage to enable comments from interested Members,  and giving sufficient time between adoption and 
implementation for economic actors to adapt. 
289. The representative of China explained that the short comment period provided in the 
notification was due to detailed c onsultations with enterprises, in cluding those from the European 
Union.  He said that a clear definition on new i ngredients for cosmetics was given in the Cosmetic 
Hygiene Supervision Regulation, and specific regulations on safety assessment of new ingredients for 
cosmetics were also formulated  in Implementing Rules of Cosmetic Hygiene Supervision Regulation 
and Cosmetic Hygiene Standard.  He stated in or der to strengthen the supe rvision on new ingredients 
for cosmetics, Application and Evaluation Guid eline of New Raw Materials for Cosmetics was 
drafted and notified to the WTO, and the list of the first batch of raw materials used was being sorted 
out.  He confirmed that SFDA would attend the third Session of Sino-EU Cosmetics Working Group 
Meeting in Brussels on 21 June,  and in-depth di scussions and exchanges were expected with EU 
counterparts on safety management of cosmetic raw materials, risk assessment evaluation, and testing 
methods for prohibited and restricted cosmetic substances. 
(xxxi)  Korea – Good Manufacturing Practice requirements for cosmetics ( G/TBT/N/KOR/301)  
290. The representative of the European Union re iterated concerns about the above-mentioned 
measure, in particular on the provision for certain facilities for cosmetics manufacturers, such as an 
exemption from the requirement of batch testi ng and from conducting quality management by lot 
number.  She referred to Korea’s confirmation that  only domestic manufacture rs would benefit from 
these derogations, and to its assertion that foreign manufacturers received similar preferential treatment, such as exemption from quality inspection under Article 9 of the Enforcement Regulation 
of the Cosmetics Act.  She argued, however, that wh ile this Order indeed provided for the possibility 
of a waiver from quality control inspection in the territory of Korea, it did not allow for the other 
derogations foreseen in the Good Manufacturing Practice Requirements for cosmetics (KCGMP).  
The European Union therefore believed that the 'pre ferential treatment' provided by the two acts were 
not equivalent and reiterated its request for Korea to ensure fair competition between domestic and 
foreign manufacturers. She informed the Committee that the issue was under discussion bilaterally.   
The representative of the European Union also enqui red as to whether Korea's responsible authority, 
the Korea Food and Drug Administration (KF DA) would recognize assessments performed, or 
certificates issued, by testing laboratories and governmental agencies of third countries proving compliance with ISO 22716 as equivalent to those proving compliance with the KCGMP - in particular since Korea had provided assurances at the last meeting that KCGMP had been developed to harmonize Korean requirements with the aforementioned international standard.  G/TBT/M/54 
Page 62  
 
  291. The representative of the United States referred  to the potential for the measure to provide 
preferential treatment for companies in complian ce with GMP standards, which offered significant 
cost advantages.  He urged Korea to ensure that rules would be applied consistently to both foreign 
and domestic producers and asked if foreign producers would be eligible for this certification.  If not, 
he stated that the measure would appear to discrim inate against foreign producers.  In addition, the 
United States believed the GMP standard to be b ased on ISO 22716 and was currently comparing the 
two documents.  He expressed concern that the tr ade group for the Korean Cosmetics Association 
(KCA) would control certification of compliance, crea ting a potential conflict of interest.  Given that 
GMP and ISO standards appeared very similar, if  not identical, he argued that Korea could accept 
certification to the ISO standard from an independent third party.  He also asked for clarification of 
the exact role of the KCA and for confirmation that submission of foreign cosmetic producers’ 
formulae was no longer a requirement for pre-market approval.  He believed th e latter issue had been 
resolved in 2008, but said that the issue had been raised again by US industry 
292. The representative of Korea confirmed that KCGMP formed part of efforts to harmonize with 
the ISO 22716 to improve the quality of cosmetic s and to protect public health from hazardous 
cosmetics.  He added that KCGMP was voluntary, with no mandatory standard foreseen.  Regarding 
the exemption from the requirement of conducting ba tch tests and conducting quality management by 
lot number, he explained that the exemption would offer preferential treatment to domestic 
manufacturers sufficiently in compliance with the requirements.  Similarly, importers of non-Korean cosmetics products could enjoy preferential tr eatment, for instance the exemption from quality 
inspection upon passing on-site inspection, under Article 9 of the Department Ordinance of 
Cosmetics. This had been adopted in 1999 and 23 importers of foreign cosmetics manufacturers had 
since benefitted from it.  In response to concerns  about the impartiality and neutrality of KCA, he 
clarified that the organization merely supporte d implementation and the body responsible for 
certification was the KFDA; he pledged to bring the ot her points raised to the attention of the KFDA.  
He noted that the European Union planned to in troduce a Cosmetics Regulation, which would enter 
into force in 2013; he asked for more inform ation on the EU’s good manufacturing practice, 
particularly the date of notifica tion and any deviation from ISO 22716. 
(xxxii)  Ukraine – Draft Technical Regulation on th e labelling of foodstuff (G/TBT/N/UKR/52) 
293. The representative of the European Union request ed clarification of the state of play of 
Ukraine’s GMO legislation, including confirmati on that only foodstuffs containing more than 0.9 
per cent of GMOs would require labelling as "with GMO" and that the statement "GMO free" would 
remain voluntary for foodstuffs with GMO content of  less than 0.1 per cent.  She urged Ukraine to 
align its legislation with internati onal practices and not to prohibit h ealth claims in food labelling, for 
which guidelines were given in the Codex Alimen tarius and which were generally permitted under 
EU legislation.  She recommended that inform ation on storage conditions only be required if 
necessary and not systematically for all products. 
294. The representative of Ukraine said that there were internal discussion on-going on possible 
modifications and amendments of the technical regulation to more adequately reflect domestic 
objectives and international commitments.  She clarif ied that the corresponding reference to standard 
DSTU4518 implied a recommended and voluntary m easure which was under revision.  Ukraine’s 
Safe Standards Committee prepared a second set of clarifications on issues including conditions for 
the identification of nutritional value recommendati ons to avoid misleading consumers.  She added 
that the regulation allowed for proper indication of  dietary functional characteristics and dietary 
supplements, following Ukrainian Health Author ity approval. She acknowledged European Union 
input on specific shelf life conditions to be indicat ed on a label and invited further comments from 
Members.  G/TBT/M/54 
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  (xxxiii)  Ecuador - Certification of Ceramic Tiles (Resolutions 17 and 18 of CONCAL)  
295. The representative of the European Union noted th at, contrary to what Ecuador had indicated 
at the previous meeting, the Resolution 18 had not been notified according to Article 2.9.2 of the TBT 
Agreement.  She asked why supplier's declarations  of conformity (SDoC) from enterprises certified 
according to ISO 9001 and issued by bodies recogni zed by Ecuador’s Accreditation Body were 
suddenly no longer accepted and whether ISO 13006 certificates issued by similarly-accredited bodies 
would be recognized.  Imports had been seriously im peded by the fact that only one laboratory had 
been accredited in Ecuador to carry out the necessar y tests and the drastically shortened validity of 
existing certificates, from one year to 90 days.  She added that requests for clarification following the last TBT Committee meeting addressed to Ecuador's  Enquiry Point had met with no response; she 
urged Ecuador to reply. 
296. The representative of Ecuador explained that Resolution 18 followed ISO 13006 
requirements.  And, although there was no obligati on to notify it under Article 2.9.2 it did fall under 
the notification contained in document G/TBT/N/EC U/44/Add.1.  In general, Ecuador was of the 
view that ISO 9001 certification was not the most a ppropriate tool for gauging technical qualities of 
products, and that ISO 9001 was intended to ensure conformity and management  of a product, rather 
than its quality.  This meant that although certain  products complied with ISO 9001, they were not in 
line with Ecuador’s technical requirements.   
297. The representative of Ecuador explained that ISO 13006 had been used as a basis for study of 
its technical regulations on ceramic tiles and the require ments of this standard had been incorporated.  
Thus these certificates of conformity were recognized when in line with N003 or other standards, or 
when they state that they are in line with ISO 13006.  With respect to certification he explained that 
both Articles 1 and 2 of Resolution 018 of CONC AL offered three options for conformity 
certification:  country of origin, country of shipment or country of destination.  He said that a single certified laboratory did not necessar ily constitute a technical barrier to trade, as the laboratory would 
have the capacity to handle the demand.  Nonethel ess, Ecuador had started to increase the number of 
laboratories and certification bodies.  He reitera ted that products with only ISO 9001 certification 
would no longer be accepted once the provisional me asure had expired.  He clarified that new 
certificates were based upon Resolution 18 of CONCAL  would maintain their one-year validity as in 
the past. 
(xxxiv)  European Communities – Regulation on Certai n Wine Sector Products (G/TBT/N/EEC/15 
and Corr.1-2; G/TBT/N/EEC/57; G/TBT/N/EEC /252 and Add.1; G/TBT/N/EEC/264 and 
Add.1) 
298. The representative of the United States expr essed concern about measures which severely 
restricted the ability of non-EU wine producers to  use common descriptive or commercially-valuable 
terms to describe their products – on the grounds that these terms were traditionally associated with 
European wines.  He noted that discussions we re on-going but the European Union still claimed 
exclusive rights to terms commonly included on wine labels worldwide.  The United States was 
unaware of any basis upon which these terms could mislead consumers and was also concerned that 
protection of these terms had been extended to la nguages other than the one for which protection was 
identified.  He added that the United States had rais ed intellectual property concerns on this issue in 
other for a as well. 
299. The representative of the European Union observe d that bilateral discussions with the United 
States were on-going and that applications filed by  US wine associations for the aforementioned 
traditional terms were under review. G/TBT/M/54 
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  (xxxv)  Norway – Proposed regulation concerning sp ecific hazardous substances in consumer 
products (G/TBT/N/NOR/17) 
300. The representative of Japan requested an expl anation of Norway’s risk assessment for the 
specified hazardous substances and stated that a publically-available risk assessment should be 
conducted for newly-specified substances, in th is case: lead, pentaclorofino, medium-chain 
chlorinated paraffin (MCCP) and perfluoro octanic acid (PFOA).  He asked for an update on the 
possible new regulation of specific hazardous substa nces and urged Norway to notify the regulation to 
the TBT Committee should it be modified. 
301. The representative of Norway explained that th e draft had been thor oughly reviewed, with 
eight substances of the 18 in the original no tification removed following a second review.  A 
subsequent review concluded that the four (referred to by Japan) of the remaining 10 substances were 
to be prioritized for regulation; she explained that  comments from earlier reviews had been considered 
when undertaking impact assessments for these four substances and they were available through the 
Norwegian Climate and Pollution Agency website.  E nglish language versions had been forwarded to 
the Japanese delegation.  She informed Members th at the Norwegian environmental authorities were 
in the process of reviewing the proposals in light of new comments received but there was no 
schedule for completion of this task or implementation of the regulation. 
(xxxvi)  Brazil - Canned Sardines - Ministerial Act Nº 406 of 10 August 2010 
302. The representative of Peru informed the Committe e that bilateral consultations with Brazil 
would soon begin on the labelling requirements for canned and tinned sardines, the results of which 
would be conveyed to the Committee in due course.   
303. The representative of the European Union al so expressed interest in the issue.  
304. The representative of Brazil confirmed Brazil's willingness to hold a bilateral dialogue with 
Peru on this issue.  
C. EXCHANGE OF EXPERIENCES   
1. Good Regulatory Practice  
305. The Secretariat introduced two background not es.  One on regulatory cooperation between 
Members (JOB/TBT/10) and the other on a list of Sources on Good Regulatory Practice 
(JOB/TBT/11).  The attention of Members was also  drawn to the draft outline of the programme for 
the Workshop on Regulatory Cooperation between Members, contained in JOB/TBT/7/Rev.1.    
306. The representative of India offered some prelim inary comments.  He suggested adding the 
word "technological" in the parenthesis of paragr aph 3; the deletion to the reference made to 
"different levels of development" in para 6(d); a nd, the need for some clarifi cation in 14(e) in terms of 
the link between the Committee's work and regulatory co-operation.  
307. The representative of El Salvador reitera ted the importance of developing country 
participation in regulatory cooperation activities.  
308. The Chairperson invited Members to comment  on the papers (the  above-mentioned JOB 
documents), including the programme for the Workshop, by 15 July 2011.17 
                                                      
17 This deadline was later extended to 15 August 2011.  G/TBT/M/54 
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  309. The representative of the United States update d the Committee on GRP developments in the 
United States.  These on-going activities included an agreement on terms of reference with Canada 
and Mexico in two bilateral regulatory coopera tion councils where there had also been much 
stakeholder interest in providing input on regulatory cooperation projects.  A similar exercise was also 
under way between the United States and the European  Union.  Further information on US regulatory 
activities would be provided at the Workshop on  Regulatory Cooperation between Members.  
310. The representative drew the Co mmittee's attention to a me morandum circulated to US 
Agencies by the US Trade Representative (USTR) an d the Office of Management and Budget (OMB) 
on the transparency obligations involved in GRP and their relationship w ith preventing unnecessary 
obstacles to trade.18  This memorandum, he said, showed how Good Regulatory Practice was good for 
business and also good for the protection of the environment, health and safety. 
311. The representative also informed the Comm ittee about the US policy principles for US 
Decision-Making Concerning Regulation and Oversi ght of Applications of Nanotechnology and 
Nanomaterials.19  This was an area that would be used in many different sectors and across many 
jurisdictions, both within the US and interna tionally. The United States' aim was to have a 
coordinated US Government approach to regula ting nanotechnology. This memorandum, he said, 
specifically encouraged coordination with the international community.  Cooperation with the 
European Union was already underway and his de legation looked forward to discussing this issue 
with other delegations. 
2. Standards 
312. Concerning standards, the Chairperson reminded the Committee that during the Fifth 
Triennial Review the Committee had considered in de pth the issue of standards.  In particular the 
Committee had looked at the issue of the development and use of standards in line with paragraph 25 
of the Triennial Review report.  The Committee had recognized the need for international standards to 
be relevant and that they effectively respond to  regulatory and market needs and scientific and 
technological developments while not creating unn ecessary obstacles to international trade.  Among 
other things, the Committee had recommended the circul ation of key studies or other research on the 
impact of standards on economic develo pment and international trade.   
313. She recalled that Members had also been inv ited to share their experiences related to the 
implementation of the TBT Agreement, includi ng the Code of Good Practice as outlined in 
paragraph 26 of the Triennial Review report - and th at the Committee had stressed the importance of 
participation in the work of international standard izing bodies.  In paragraph 27(a) of other Triennial 
Review report the Committee had encouraged Members,  Observers, Organizations and other relevant 
bodies involved in the development of standards, to exchange information on initiatives implemented 
successfully achieved and obstacles encountered.  Sh e invited Members to begin an exchange of 
experiences in this respect. 
                                                      
18 http://www.whitehouse.gov/sites/defau lt/files/omb/memoranda/2011/m11-23.pdf .  
19 http://www.whitehouse.gov/sites/de fault/files/omb/inforeg/for-agen cies/nanotechnology-regulation-
and-oversight-principles.pdf . G/TBT/M/54 
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  3. Conformity Assessment  
314. Representatives of the ILAC and IAF made a joint presentation of their organizations.
20  The 
following are a few of the key messages delivered . The full presentation was circulated as document 
G/TBT/GEN/17.21   
(a) ILAC is the global authority for laboratory and inspection body accreditation.22 IAF 
oversees accreditation in the fields of the certification of management systems, 
personnel and products.  The objective of bot h organizations is the same: one test 
accepted everywhere, one conformity assessment result accepted in every market place.   
(b) IAF and ILAC determine the competence of accreditation bodies by peer evaluation 
based on an ISO/IEC standard (ISO/IEC 17040) on how peer evaluation should be 
conducted. Most of the peer evaluations ar e coordinated and conducted at the regional 
level.  The ISO/IEC 17000 series is the international standard used for conformity assessment and accreditation.   
(c) The main tool used by the two organizations is multilateral, mutual-recognition 
arrangements among accreditation bodies (for IL AC it is called an MRA and for IAF 
an MLA).  The vision is to have a single world-wide programme of conformity 
assessment which reduces risks for business, regulators and the consumer by ensuring 
that accredited services can be relied upon.   
(d) The ILAC and IAF arrangements consis t of ILAC and IAF accreditation body 
members that are deemed competent thr ough a peer evaluation process to confirm 
conformance to ISO/IEC 17011 and the IAF-ILAC A series documents.  
Accreditation bodies are then allowed to sign the ILAC MRA or IAF MLA.   
Signatories must recognize certificates, repor ts, and results issued by organisations 
accredited by all other members of the arrangements.  These arrangements provide businesses with assurance that equivalent overseas conformity assessment bodies 
operate to the same standard as those in their own country. This recognition 
contributes to removing unnecessary barriers to trade by eliminating redundant conformity assessment procedures.  The idea is that an organization can be accredited once and then have that accreditation recognized anywhere in the world. 
(e) There are 72 ILAC MRA Signatories representing 59 economies and there are 49 IAF 
MLA Signatories, representing 47 economies.   
(f) Both ILAC and IAF provide assistance to developing countries to help them develop 
their conformity assessment and accreditation infrastructures. 
                                                      
20 The presentation was jointly made by Mr Randy Dougherty and Mr Peter Unger.  Mr Dougherty is 
the Vice President of the ANSI ASQ National Accredita tion Board which is the United States' recognized 
national accreditation body for management  system certification bodies.  He is currently Chair of the IAF and 
the IAF Executive Committee.  Mr Peter Unger is Pr esident and CEO of the American Association for 
Laboratory Accreditation, a non-prof it membership organization administering a comprehensive laboratory 
accreditation systems.   
21 More information can be obtained at www.ilac.org  and www.iaf.nu . 
22 Accreditation is defined as: "Independent evaluation of conformity assessment bodies against 
recognized standards to ensure their impartiality and comp etence to carry out specific activities, such as tests, 
calibrations, inspections and certifications".  G/TBT/M/54 
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  315. The representative of Egypt asked for some clarification about the proportion of "regulators" 
(77 per cent) that accepted results from accredited organizations:  what did the remaining percentage 
consist of?  Were these non-signatories? 
316. The representative of China asked whether the CPSC23 (a US body) automatically accepted 
test results issued by testing laboratories of exporting Members as long as they had fulfilled the 
criteria under ILAC, for instance with respect to toys - an issue that had been raised as a specific trade 
concern in the Committee.  In China's understanding, it was primarily the technical competence of 
testing laboratories that needed to be taken into account for regulators to decide whether (or not) to 
accept the test results of laboratories.  Yet, the CPSIA24 set additional and unr easonable requirements 
for governmental laboratories and this was a primar y reason for the CPSC to refuse to accept Chinese 
governmental laboratories.  Is it justifiable for a laboratory to be denied recognition by regulators 
solely because of the governmental background of it? 
317. The representative of Pakistan asked if MRAs  and MLAs were cove red under international 
treaties (or international law), governable under the Vi enna Treaty of Conventions.  He also asked for 
some clarification about the membership of ILAC.  He also asked about public sector involvement in 
certification activities.   
318. The representative of New Zealand noted that sev eral slides in the presentation had mentioned 
the growing acceptance by regulators of the value of  accreditation.  She asked if this was because 
regulators themselves had seen value in accreditation and had therefore provided for this in their 
regulatory frameworks. Or was it because a ccreditation had grown through government to 
government MRAs, or were there other reasons?  This was important because the Committee was 
involved in work on guidelines for trade facilitation mechanisms and insights from the ILAC and/or 
IAF could be useful.  
319. The representative of ILAC explained, with respect to the question from Egypt, that the 
77 per cent figure was based on self-declaration am ong ILAC members (when reporting on the degree 
of acceptance by the regulators of accreditation).  This was not necessarily directly related to the 
ILAC MRA but was about the degree that regulat ors were using the national accreditation body.  
Although the majority had declared that, indeed, th ere were regulatory agencies in their country that 
were using accreditation, a smaller share (the rema ining 23 per cent) had not succeeded in convincing 
regulators to use accreditation.  He noted that co mmunication with regulators had been on the increase 
over the years.   
320. On the question regarding the CPSC (from China) the representative of the ILAC said that he 
could not speak officially for the CPSC.  He noted , nevertheless, that with respect to government 
laboratories impartiality and accuracy was importan t:  it was important that laboratories had the 
equivalent to what was required in ISO 17,025 with re gard to being impartial.  Testing needed to be 
unbiased. The conformity assessment standards of ISO and IEC, he said, focused very heavily on the 
impartiality of the body, i.e. to have confidence that conformity assessment results could be relied 
upon.  The conformity assessment body has to be able  to demonstrate that it was not influenced by 
outside forces.   
321. On the issues of international law (question from Pakistan), the representative of IAF noted 
that this was precisely one of the reasons that ILAC and IAF did not refer to multilateral 
mutual-recognition agreements  - because an "agreement" was consid ered to pertain to governments.  
Hence the word "arrangements" was used - but it w as still about mutual recognition.  This was not 
necessarily government-to-government recognition, he explained.  It was recognition between 
                                                      
23 http://www.cpsc.gov/ . 
24 http://www.cpsc.gov/ab out/cpsia/cpsia.html . G/TBT/M/54 
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  conformity assessment practitioners: primarily accredita tion bodies - the mutual recognition of results 
that were produced by the accredited laboratories, or accredited conformity assessment bodies.  In other words, this was a private sector activity and not government-to-government mutual recognition 
agreements  or multilateral agreements.   
322. With respect to membership, the representative of IAF noted that while membership in ILAC 
was limited to accreditation bodies, the IAF had decide d some time ago that it was important to give 
voice to the stakeholders: the bodies that were actual ly being accredited, the industry that had being 
served.  Hence, while individual companies coul d not become IAF members, industry associations 
could - and the same was valid for conformity asse ssment bodies.  Individual conformity assessment 
bodies could not become members of IAF, but they  could become associate members.  On public 
sector involvement, it was noted that most certification bodies were actually private-sector 
organizations.  Normally, certification was done in the private sector although there could be some 
government bodies or certification bodies that were government-based.   
323. The representative of ILAC stressed that his organization relied on inte rnational standards: 
most activities related to harmonization were done thr ough ISO and IEC.  In his view this was one of 
the drivers for the growing acceptance by regulators of accreditation (New Zealand's question).  There 
was, in his view, a desire by regulators to pl ay within the global community and international 
standards provided a mechanism better than any ot her kind of relative mechanism.  The ILAC and 
IAF provided a mechanism through which the privat e sector could work in close cooperation with 
official regulators to provide confidence in the safety of products.  A good example of how this 
worked effectively and in a highly regulated ar ea was the Canadian Medical Device Conformity 
Assessment System.  This system, developed several years ago, allowed for the private sector to have 
responsibility for overseeing lower-risk medical devi ce products whereas the Canadian Government 
had kept responsibility for regulating the very high ri sk medical devices.  So the government had been 
able to focus their resources on the higher risk and work closely with the private sector conformity 
assessment area to handle some of the lower risk products.  This was also an example of how the 
efficient use or resources was also a significant driver for governments. 
324. The representative of India asked, with respect  to the issue of membership, about the 
proportion of accreditation bodies from developing countries compared to developed countries.  He 
asked what types of bodies that we re members (inspection, certification and testing bodies).  He also 
asked about the concept of international standards and asked whether there w as any specific definition 
used for international standards in the IAF and ILAC context. 
325. The representative of the United States asked a bout the obligation of signatories to promote 
the use of IAF and ILAC within their countries:  what were those obligations?  And what was the 
level of implementation of such obligations?  He also asked about support provided by ILAC and IAF 
to developing countries to develop accreditation infrastructure.  Sometimes, in discussions, a reason given for not using ILAC and IAF was a perceived need to  protect the development of their emerging 
infrastructure.   
326. The representative of Australia asked for clarif ication about the relationship between ILAC 
and IAF: was there an MoU?  Also, how often was the competency of accreditation bodies reviewed? 
327. The representative of Canada asked for clarifi cation about the challenges that ILAC and IAF 
faced in convincing regulatory authorities to u se accreditation.  What were the reasons that 
accreditation was perhaps not more widespread?  In  addition he wondered if some work was being 
undertaken on some form of guidelines.  
328. The representative of the European Union asked  whether there had been any attempts to 
merge the two organizations.  He also asked for cl arification on how ILAC and IAF cooperated with  G/TBT/M/54 
 Page 69 
 
 
  regulators in order to ensure that the results of  accreditation served all the regulators' needs in 
different countries.  In addition, the representativ e of the European Union asked whether sectoral 
schemes existed in order to better link accreditation to the needs of specific product areas.  With 
respect to peer evaluation, he asked about the training of "lead assessors" and how ILAC and IAF ensured uniformity in assessment. 
329. The representative of China asked for some more  detail about the issue of impartiality and 
technical competence of laboratories.  While he understood the importance of accreditation to ensure 
the impartiality and technical competence of testing laboratories, he also noted there was an international standard (ISO/IEC 17,025) for laborat ory accreditation.  It was his understanding that 
gaining accreditation under ILAC in accordance with this standard means the testing laboratories had 
demonstrated impartiality and technical competence regardless of the nature of the technical 
laboratory; that is regardless of whether it was a governmental laboratory or a private one.  In this 
sense the regulators had the obligation to treat gove rnment laboratories and private laboratories in the 
same manner as long as the testing laboratory w as accredited under ILAC in accordance with the 
relevant international standard.  Nevertheless, China was faced with a situation where some regulatory 
authorities of some Members did not automatical ly accept the testing results issued by testing 
laboratories accredited under ILAC but rather impos ed additional and WTO-inconsistent requirements 
on government laboratories.   
330. The representative from ILAC noted that indeed there existed sector-specific requirements in 
certain areas and these could come from many different standardization bodies.  On the use of the 
ILAC MRA, he noted that there were some ag encies that were unwilling to use accreditation in 
particular regulated fields - it was sometimes difficult  to convince certain sectors of the market place, 
consumers in particular, that were sceptical of pr ivate sector solutions.  Consumers did not always 
believe that the private sector could be as impa rtial as a government regulator, government inspector 
or a government laboratory.   With respect to de veloping countries, ILAC did have a modest budget to 
help developing countries; it was currently partne ring with donor agencies to develop national 
accreditation bodies or to join a multi-economy accreditation system.  Indeed ILAC was encouraging 
and did have rules to accept multi-economy accreditati on bodies: some countries were very small and 
would not necessarily have their own national system for accreditation but their conformity assessment bodies could then be accredited by a ne ighbouring accreditation body.  Such cross-frontier 
accreditation was accepted.  Also, there existed an  IAF/ILAC/UNIDO MoU that set out cooperation 
with UNIDO in support and promotion of develo pment of accreditation infrastructure in developing 
countries. 
331. The representative of ILAC also confirmed that the MoU between IAF and ILAC committed 
both organizations to close cooperation on common issues.  This was evid ent through joint peer 
evaluation, for example.  Regarding the issue of merging the two organizations, a formal vote had been taken in 2010 on a merger and although the ma jority of participants in each organization had 
been in favour of merger, a three-fourths vote in IL AC and two-thirds in IAF was needed to proceed 
and neither threshold had been met.  Ther efore a merger had not been undertaken.  
332. The representative of IAF explained that for both IAF and ILAC the MLAs and MRAs had 
moved quicker with developed countries becau se they had accreditation bodies that had been 
established and had been working for a longer pe riod of time.  Nevertheless, numerically the 
predominant members were from developing economies (i n both ILAC and IAF).  He stressed that all 
members that joined the bodies ha d to work actively to becoming an MLA signatory and progress was 
checked.  
333. The Chairperson thanked the representative fro m ILAC and IAF for their very informative 
presentations  G/TBT/M/54 
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  334. The representative from Thailand informed th e Committee that Thailand would host the 
annual joint meeting of the international accreditatio n forum and international laboratory accreditation 
co-operation.  IAF/ILAC 2011 Joint Annual Mee ting. This meeting would take place during on 
2-11 November 2011 in Bangkok.  She invited Me mbers of the TBT Committee to attend this 
meeting. 
4. Transparency 
335. The representative from the United States thanked th e Secretariat for providing an update of 
the document containing Decisions and Recommendations of the Committee since 1995 
(G/TBT/1/Rev.10).  
5.  Technical Assistance 
336. The representatives from Sweden and Kenya25 presented the results of the Swedish 
Mentorship Programme which had b een launched in November 2008.  The following are a few of the 
key messages delivered; the full presentation is  contained in document G/TBT/GEN/16.   
(a) The Programme, which is managed by the Swedish National Board of Trade (SNBT) 
and financed by the Swedish Interna tional Development Co-operation Agency 
(SIDA), is between Sweden and six sub-Sa haran East African Countries:  Burundi, 
Kenya, Rwanda, Tanzania , Uganda and Zambia. 
(b) It emphasizes, inter alia : attendance to the TBT Committee meetings; building 
national infrastructure for transparency (notification) and provision of comments on other WTO Members’ notifications (of draft measures); building a network of civil servants among participating countries; building a network between private and 
public sectors and interested parties (e.g. regional trade groupings and chambers of 
commerce). 
(c) From the mentee's perspective an important starting point was the identification of the 
root causes for lack of implementation of the TBT Agreement in their countries:  These included: poor feedback on notificati ons; inadequate physical infrastructure 
and regulatory framework;  unclear definiti on of institutional roles with overlap of 
mandates between various institutions;  poor national co-ordination mechanisms 
between various regulatory authorities; inade quate financial resources;  low capacity 
of personnel to undertake implementation t asks; and, ineffective mechanisms for 
collecting information about regulations (lack of databases). 
(d) There were a number of tangible results. For instance, between 2008 and 2010 there 
had been an increase in the number of notifi cations made to the TBT Committee:  in 
2008 there were 37; by 2010 combined notifications from the six countries were 226;  national enquiry pods had been established (where none existed before);  improved 
engagement in TBT Committee meetings and enhanced understanding of the TBT 
Agreement among stakeholders; improved national coordinatio n (mechanisms had 
been developed) both at the domestic le vel and between capital-based experts and 
missions in Geneva; and, enhanced regi onal co-operation between countries involved 
in the programme. 
                                                      
25 Presentation by Mr. Christer Arvius from the Swedish National Board of Trade and 
Ms Lucy Wanjiru Ikonya, Manager of Trade Affairs at  the Kenya Bureau of Stan dards (KEBS), Nairobi (on 
behalf of the mentees).  G/TBT/M/54 
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  (e) The mentees thanked SIDA and the Swedish National Board of Trade (SNBT) for 
their support and called for follow-up with respect to work under way. 
D. OTHER MATTERS  
1. Sixth Triennial Review of the TBT Agreement (2012) 
337. The Chairperson noted that there had been, since November 2009, a robust discussion on 
issues falling under the Agenda Item 2.C. (Excha nge of Experiences).  She reminded the Committee 
of the upcoming Sixth Triennial Review and the need  to start preparations.  She therefore suggested 
that the Committee hold an informal meeting afte r the summer to discuss  matters arising under 
Agenda Item 2.C.  She suggested that this opportuni ty also be used to finalize the programme for the 
Workshop on Regulatory Cooperation between Member s.  The date for the informal meeting was 
subsequently set for the morning of 23 September 2011.26 
2. The Great East Japan Earthquake and Tsunami Disaster 
338. The representative of Japan expressed his country's  gratitude for various kinds of support by 
WTO Members after the Great East Japan Earthquake and Tsunami Disaster.  He reaffirmed Japan's 
strong commitment to international trade.  Regard ing the safety of industrial products exported from 
Japan, he said that these products were manufactured in factories outside of the no-entry zone and 
remained under strict quality control.  It was ther efore unlikely that such products would be affected 
by radioactive material.  Safety was ensured.  In  addition to monitoring the level of radiation across 
the country, Japan published data on radiation levels in ports and ai rports.  Moreover, a guideline on 
radiation measurements for export containers a nd ocean going ships had been developed and 
published, and an attestation of measurement resu lts had begun at some ports including Yokohama 
since 28 April 2011.  Japan would continue to provi de the international community with prompt and 
accurate information on its response to the nuclear accident and would ensure the highest level of 
transparency.  Japan would like to request WTO Me mbers to respond to this situation on scientific 
grounds. 
III. TECHNICAL COOPERATION ACTIVITIES 
339. The Chairperson drew the Committee's attention to a document containing the Secretariat's 
technical assistance activities (G/TBT/GEN/122). 
IV. OBSERVERS 
A. UPDATE FROM OBSERVERS  
340. The representative of ISO highlighted the impor tance that ISO placed on technical assistance 
and training in supporting its devel oping country members which, he said constituted three-quarters of 
its current membership. Recent activities in this  area included the brochure "Developing Talent"27 
containing an overview of all technical assistan ce and training activities provided by ISO to its 
members.  While these activities were mainly direct ed at ISO members, the representative highlighted 
the support that had also been given to sub-regiona l and regional organizations in training activities.  
Such organizations needed training in standardi zation as their members dealt directly with regional 
trade of products and services and therefore harm onization of standards and conformity assessment 
procedures were critical.   He drew the Committee' s attention to a new activity launched in 2011, to 
help identify gaps in best practices.  These gaps, he  said, would be addressed through targeted actions 
                                                      
26 Chairperson's fax to WTO Members of 15 July 2011. 
27 Available on the ISO website at http://www.iso.org/iso/publications_and_e-products/about_iso.htm.  G/TBT/M/54 
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  over the course of a year.  Initially, work was be ing undertaken with 13 standard bodies, but the 
programme would be extended to other ISO members - in particular developing country members.  
He also highlighted the ISO guide on engaging stakeholders and building consensus published in 
December 2010.
28   
341. The representative of the IEC drew the Committ ee's attention to the IEC report to the TBT 
Committee.29 She highlighted new developments in IEC in ternational standardization such as the new 
IEC Technical Committee 117 on Solar Thermal Electric Plan. Another development was the 
intention to reduce the time line in the delivery of fi nal standards.  A decision would be taken on this 
at the IEC Standardization Management Board in 2012. With regard to capacity building, she 
highlighted the IEC's participation in an ev ent organized by the African Electrotechnical 
Standardization Commission to be held in Nairobi  in September 2011.  On conformity assessment 
activities, the representative informed the Committe e that the  IEC Conformity Assessment Board 
(CAB) had circulated a survey on conformity asse ssment aspects on electrical energy efficiency in 
developing countries and had received feedback from fo rty-two affiliate countries.  It was also noted 
that the IEC had nominated Phuntsho Wangdi from the newly formed Bhutan Standards Bureau, as 
the new Affiliate Leader and informed th e Committee that the IEC would hold its 75th Annual 
Meeting in Melbourne, Australia from 24-28 October 2011. 
342. The representative of the UNECE inv ited the Committee to attend the 21st session of the 
Working Party on Regulatory Cooperation and Sta ndardization Policies (WP6) which would take 
place on 25-27 October 2011 and would include a workshop on traceability.30  This session, she said, 
would also look at new recommendations on market surveillance policies, risk management in 
regulatory systems, and contingency planning in  regulatory policies.  The representative also 
highlighted the formal launch a database of market surveillance authorities.  In addition, she informed 
the Committee on progress made in the promotion of regulatory convergence in specific sectors, in 
particular the initiative on equipment used in enviro nments with an explosive atmosphere.  A meeting 
of regulators in this sector would take place in  Croatia in September 2011 where regulators would 
present their different regulatory approaches and di scuss how the UNECE proposal could be used to 
promote regulatory convergence. 
343. The representatives of the ITC, Codex and the OIML31 provided updates to the Committee on 
their on-going activities in developing countries a nd other work relevant to the TBT Committee. 
B. REQUESTS FOR OBSERVER STATUS IN THE TBT COMMITTEE  
344. The Chairperson drew the Committee's atten tion to the document G/TBT/GEN/2/Rev.3 
containing the list of bodies applying for observer stat us in the Committee.  She invited Members to 
consult with relevant authorities regarding the lis t of pending requests so that the Committee could 
take a decision on these.  
                                                      
28 http://www.iso.org/iso/publications_and_e-produc ts/standards_development_publications.htm ). 
29 G/TBT/GEN/118. 
30 http://live.unece.org/trade/wp6/doc uments/2011/2011_docslist.html . 
31 G/TBT/GEN/119, G/TBT/ GEN/120, G/TBT/GEN/121.  G/TBT/M/54 
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V. DATE OF NEXT MEETING 
345. The next regular meeting of the TBT Committee will take place on 10-11 November 2011.  It 
will be preceded by the Workshop on Regulator y Cooperation Between Members on 8-9 November 
2011.  The following dates have been preliminarily ag reed for meetings in 2012:  21-22 March, 14-15 
June and 7-8 November. 
__________